Oral product and method of manufacture

ABSTRACT

A composition is provided, the composition including a binder system in an amount of at least about 5% by weight, based on the total weight of the composition, and at least one active ingredient and/or flavoring agent. The binder system includes at least one thermoplastic binding material and at least one plasticizer. The composition is typically substantially free of unbleached tobacco material, excluding any nicotine component present.

FIELD OF THE DISCLOSURE

The present disclosure relates to flavored products intended for humanuse. The products are configured for oral use and deliver substancessuch as flavors and/or active ingredients during use. Such products mayinclude tobacco or a product derived from tobacco, or may betobacco-free alternatives.

BACKGROUND

Tobacco may be enjoyed in a so-called “smokeless” form. Particularlypopular smokeless tobacco products are employed by inserting some formof processed tobacco or tobacco-containing formulation into the mouth ofthe user. Conventional formats for such smokeless tobacco productsinclude moist snuff, snus, and chewing tobacco, which are typicallyformed almost entirely of particulate, granular, or shredded tobacco,and which are either portioned by the user or presented to the user inindividual portions, such as in single-use pouches or sachets. Othertraditional forms of smokeless products include compressed oragglomerated forms, such as plugs, tablets, or pellets. Alternativeproduct formats, such as tobacco-containing gums and mixtures of tobaccowith other plant materials, are also known. See for example, the typesof smokeless tobacco formulations, ingredients, and processingmethodologies set forth in U.S. Pat. Nos. 1,376,586 to Schwartz; U.S.Pat. No. 4,513,756 to Pittman et al.; U.S. Pat. No. 4,528,993 toSensabaugh, Jr. et al.; U.S. Pat. No. 4,624,269 to Story et al.; U.S.Pat. No. 4,991,599 to Tibbetts; U.S. Pat. No. 4,987,907 to Townsend;U.S. Pat. No. 5,092,352 to Sprinkle, III et al.; U.S. Pat. No. 5,387,416to White et al.; U.S. Pat. No. 6,668,839 to Williams; U.S. Pat. No.6,834,654 to Williams; U.S. Pat. No. 6,953,040 to Atchley et al.; U.S.Pat. No. 7,032,601 to Atchley et al.; and U.S. Pat. No. 7,694,686 toAtchley et al.; US Pat. Pub. Nos. 2004/0020503 to Williams; 2005/0115580to Quinter et al.; 2006/0191548 to Strickland et al.; 2007/0062549 toHolton, Jr. et al.; 2007/0186941 to Holton, Jr. et al.; 2007/0186942 toStrickland et al.; 2008/0029110 to Dube et al.; 2008/0029116 to Robinsonet al.; 2008/0173317 to Robinson et al.; 2008/0209586 to Neilsen et al.;2009/0065013 to Essen et al.; and 2010/0282267 to Atchley, as well asWO2004/095959 to Arnarp et al., each of which is incorporated herein byreference. It is noted that certain types of oral products that containtobacco substitutes (or combinations of tobacco and tobacco substitutes)also have been proposed. Certain types of oral products have beenemployed to contain nicotine, such as those used for nicotinereplacement therapy (NRT) types of products (e.g., a pharmaceuticalproduct distributed under the tradename ZONNIC® by Niconovum AB).

Smokeless tobacco product configurations that combine tobacco materialwith various binders and fillers have been proposed more recently, withexample product formats including lozenges, pastilles, gels, extrudedforms, and the like. See, for example, the types of products describedin US Patent App. Pub. Nos. 2008/0196730 to Engstrom et al.;2008/0305216 to Crawford et al.; 2009/0293889 to Kumar et al.;2010/0291245 to Gao et al; 2011/0139164 to Mua et al.; 2012/0037175 toCantrell et al.; 2012/0055494 to Hunt et al.; 2012/0138073 to Cantrellet al.; 2012/0138074 to Cantrell et al.; 2013/0074855 to Holton, Jr.;2013/0074856 to Holton, Jr.; 2013/0152953 to Mua et al.; 2013/0274296 toJackson et al.; 2015/0068545 to Moldoveanu et al.; 2015/0101627 toMarshall et al.; and 2015/0230515 to Lampe et al., each of which isincorporated herein by reference.

Certain types of pouches or sachets have been employed to containcompositions adapted for oral use. See for example, the types ofrepresentative smokeless tobacco products, as well as the varioussmokeless tobacco formulations, ingredients and processingmethodologies, referenced in the background art set forth in U.S. Pat.Pub. Nos. 2011/0303511 to Brinkley et al. and 2013/0206150 to Duggins etal.; which are incorporated herein by reference. During use, thosepouches or sachets are inserted into the mouth of the user, and watersoluble components contained within those pouches or sachets arereleased as a result of interaction with saliva.

Certain commercially available smokeless tobacco products, such asproducts commonly referred to as “snus,” comprise ground tobaccomaterials incorporated within sealed pouches. Representative types ofsnus products have been manufactured in Europe, particularly in Sweden,by or through companies such as Swedish Match AB (e.g., for brands suchas General, Ettan, Goteborgs Rape and Grovsnus); Fiedler & Lundgren AB(e.g., for brands such as Lucky Strike, Granit, Krekt and Mocca); JTISweden AB (e.g., for brands such as Gustavus) and Rocker Production AB(e.g., for brands such as Rocker). Other types of snus products havebeen commercially available in the U.S.A. through companies such asPhilip Morris USA, Inc. (e.g., for brands such as Marlboro Snus); U.S.Smokeless Tobacco Company (e.g., for brands such as SKOAL Snus) and R.J. Reynolds Tobacco Company (e.g., for brands such as CAMEL Snus). Seealso, for example, Bryzgalov et al., 1N1800 Life Cycle Assessment,Comparative Life Cycle Assessment of General Loose and Portion Snus(2005); which is incorporated herein by reference.

Various types of snus products, as well as components for those productsand methods for processing components associated with those products,have been proposed. See, for example, U.S. Pat. No. 8,067,046 to Schleefet al. and U.S. Pat. No. 7,861,728 to Holton, Jr. et al.; US Pat. Pub.Nos. 2004/0118422 to Lundin et al.; 2008/0202536 to Torrence et al.;2009/0025738 to Mua et al.; 2011/0180087 to Gee et al.; 2010/0218779 toZhuang et al.; 2010/0294291 to Robinson et al.; 2010/0300465 toZimmermann; 2011/0061666 to Dube et al.; 2011/0303232 to Williams etal.; 2012/0067362 to Mola et al.; 2012/0085360 to Kawata et al.;2012/0103353 to Sebastian et al. and 2012/0247492 to Kobal et al.; andPCT Pub. Nos. WO 05/063060 to Atchley et al. and WO 08/56135 to Onno;which are incorporated herein by reference. In addition, certain qualitystandards associated with snus manufacture have been assembled as aso-called GothiaTek standard. Furthermore, various manners and methodsuseful for the production of snus types of products have been proposed.See, for example, U.S. Pat. No. 4,607,479 to Linden and U.S. Pat. No.4,631,899 to Nielsen; and US Pat. Pub. Nos. 2008/0156338 to Winterson etal.; 2010/0018539 to Brinkley et al.; 2010/0059069 to Boldrini;2010/0071711 to Boldrini; 2010/0101189 to Boldrini; 2010/0101588 toBoldrini; 2010/0199601 to Boldrini; 2010/0200005 to Fallon; 2010/0252056to Gruss et al.; 2011/0284016 to Gunter et al.; 2011/0239591 to Gruss etal.; 2011/0303511 to Brinkley et al.; 2012/0055493 to Novak III et al.and 2012/0103349 to Hansson et al.; and PCT Pub. Nos. WO 2008/081341 toWinterson et al. and WO 2008/146160 to Cecil et al.; which areincorporated herein by reference. Additionally, snus products can bemanufactured using equipment such as that available as SB 51-1/T, SBL 50and SB 53-2/T from Merz Verpackungmaschinen GmBH.

BRIEF SUMMARY

The present disclosure relates to an oral product adapted for release ofa water-soluble component therefrom. The oral products described hereincan incorporate binder systems, wherein the binder system possesses orexhibits thermoplastic properties, characteristics or behaviors. Forexample, the binder system can incorporate at least one type of bindingagent that exhibits thermoplastic properties, characteristics orbehaviors (e.g., the binding agent can be composed of at least onethermoplastic polymeric material). Additionally, the binder system canincorporate ingredients or materials so as to provide a binding agentthat exhibits thermoplastic characteristics (e.g., the binding agent canbe composed of at least one thermoplastic binding material incombination with a plasticizer). In various embodiments, thethermoplastic binder system can comprise at least one thermoplasticpolymer, at least one additional binding material, and at least oneplasticizer.

In certain embodiments, the oral product composition can contain atobacco-derived product, such as a particulate tobacco material,nicotine, particulate non-tobacco material (e.g., microcrystallinecellulose) that has been treated to contain nicotine and/or flavoringagents, or fibrous plant material (e.g., beet pulp fiber) treated tocontain a tobacco extract. In various embodiments, the oral product is asmokeless tobacco product or nicotine replacement therapy product.

The invention includes, without limitation, the following embodiments.

Embodiment 1: A composition, comprising: a thermoplastic binder systemin an amount of at least about 5% percent by weight, based on total dryweight of the composition; and at least one of a flavoring agent and anactive ingredient; wherein the thermoplastic binder system comprises atleast one thermoplastic polymer and at least one plasticizer; whereinthe composition is substantially free of unbleached tobacco material,excluding any nicotine component present.

Embodiment 2: A composition according to embodiment 1, wherein the atleast one thermoplastic polymer is selected from the group consisting ofcellulose ethers, polyvinyl alcohol, polyvinyl acetate, aliphaticpolyester, polyvinyl polypyrrolidone, maltodextrin, pullulan,polyethylene oxide, natural gums, and blends thereof.

Embodiment 3: A composition according to any of embodiments 1-2, whereinthe at least one thermoplastic polymer is a cellulose ether selectedfrom the group consisting of hydroxypropyl cellulose, ethylcellulose,hydroxypropyl methylcellulose, and blends thereof.

Embodiment 4: A composition according to any of embodiments 1-3, whereinthe at least one thermoplastic polymer exhibits thermoplastic behaviorat temperatures less than about 100° C.

Embodiment 5: A composition according to any of embodiments 1-4, whereinthe thermoplastic binder system comprises at least one of pullulan, gumarabic, and xanthan gum.

Embodiment 6: A composition according to any of embodiments 1-5, whereinthe at least one plasticizer comprises a plasticizer selected from thegroup consisting of glycerin, propylene glycol, polypropylene glycol,polyethylene glycol, sorbitol, maltitol, polyglycitol, erythritol,isomalt, xylitol, mannitol, and blends thereof.

Embodiment 7: A composition according to any of embodiments 1-6, whereinthe at least one plasticizer is in the form of a plasticizer blendcomprising: at least one of sorbitol, maltitol, and polyglycitol; atleast one of erythritol, isomalt, xylitol, and mannitol; and at leastone of glycerin, propylene glycol, polypropylene glycol, andpolyethylene glycol.

Embodiment 8: A composition according to any of embodiments 1-7, whereinthe at least one thermoplastic polymer has a softening temperature, andwherein the at least one plasticizer is capable of lowering thesoftening temperature by about 20° C. or more.

Embodiment 9: A composition according to any of embodiments 1-8, whereinthe active ingredient is selected from the group consisting of anicotine component, botanicals, nutraceuticals, stimulants, amino acids,vitamins, cannabinoids cannabimimetics, terpenes, and combinationsthereof.

Embodiment 10: A composition according to any of embodiments 1-9,comprising from about 0.001 to about 10% by weight of a nicotinecomponent, calculated as the free base and based on the total dry weightof the composition.

Embodiment 11: A composition according to any of embodiments 1-10,wherein the composition is substantially free of tobacco material,excluding any nicotine component present.

Embodiment 12: A composition according to any of embodiments 1-11,wherein the thermoplastic binder system is present in an amount of atleast about 20% percent by weight, based on total dry weight of thecomposition.

Embodiment 13: A composition according to any of embodiments 1-12,comprising: about 5 to about 50% by dry weight thermoplastic bindingsystem; about 5 to about 75% by dry weight of filler; about 0.1 to about5% by dry weight of sweetener; about 0.5 to about 7.5% by dry weight ofsalt; and about 1 to about 10% by dry weight of one or more activeingredients, flavoring agents, or combinations thereof.

Embodiment 14: A method of forming a composition, comprising: contactinga thermoplastic binder system with at least one of an active ingredientand a flavorant to provide a mixture; subjecting the mixture to anelevated temperature; forming the mixture into a desired shape of anoral product; and cooling the oral product; wherein the thermoplasticbinder system comprises at least one thermoplastic polymer and at leastone plasticizer; wherein the composition is substantially free ofunbleached tobacco material, excluding any nicotine component present.

Embodiment 15: A method according to embodiment 14, wherein the at leastone thermoplastic polymer is selected from the group consisting ofcellulose ethers, polyvinyl alcohol, polyvinyl acetate, aliphaticpolyester, polyvinyl polypyrrolidone, maltodextrin, pullulan,polyethylene oxide, natural gums, and blends thereof.

Embodiment 16: A method according to any of embodiments 14-15, whereinthe at least one thermoplastic polymer exhibits thermoplastic behaviorat temperatures less than about 100° C.

Embodiment 17: A method according to any of embodiments 14-16, whereinthe at least one plasticizer comprises a plasticizer selected from thegroup consisting of glycerin, propylene glycol, polypropylene glycol,polyethylene glycol, sorbitol, maltitol, polyglycitol, erythritol,isomalt, xylitol, mannitol, and blends thereof.

Embodiment 18: A method according to any of embodiments 14-17, whereinthe active ingredient is selected from the group consisting of anicotine component, botanicals, nutraceuticals, stimulants, amino acids,vitamins, cannabinoids cannabimimetics, terpenes, and combinationsthereof.

Embodiment 19: A method according to any of embodiments 14-18, whereinthe composition is substantially free of tobacco material, excluding anynicotine component present.

Embodiment 20: A method according to any of embodiments 14-19, whereinthe thermoplastic binder system is present in an amount of at leastabout 10% percent by weight, based on total dry weight of thecomposition.

Embodiment 21: An oral product prepared according to the method of anyof embodiments 14-20.

These and other features, aspects, and advantages of the disclosure willbe apparent from a reading of the following detailed description. Theinvention includes any combination of two, three, four, or more of theabove-noted embodiments as well as combinations of any two, three, four,or more features or elements set forth in this disclosure, regardless ofwhether such features or elements are expressly combined in a specificembodiment description herein. This disclosure is intended to be readholistically such that any separable features or elements of thedisclosed invention, in any of its various aspects and embodiments,should be viewed as intended to be combinable unless the context clearlydictates otherwise.

DETAILED DESCRIPTION

The present invention now will be described more fully hereinafter. Thisinvention may, however, be embodied in many different forms and shouldnot be construed as limited to the embodiments set forth herein; rather,these embodiments are provided so that this disclosure will be thoroughand complete, and will fully convey the scope of the invention to thoseskilled in the art. As used in this specification and the claims, thesingular forms “a,” “an,” and “the” include plural referents unless thecontext clearly dictates otherwise.

The disclosure generally provides products configured for oral use. Theterm “configured for oral use” as used herein means that the product isprovided in a form such that during use, saliva in the mouth of the usercauses one or more of the components of the mixture (e.g., flavoringagents and/or nicotine) to pass into the mouth of the user. In certainembodiments, the product is adapted to deliver components to a userthrough mucous membranes in the user's mouth and, in some instances,said component is an active ingredient (including, but not limited to,for example, nicotine) that can be absorbed through the mucous membranesin the mouth when the product is used.

In particular, the disclosure provides products in the form of a mixtureof one or more components, including at least one active agent and/or atleast one flavorant and a binder system. The active agent(s) and/orflavorant(s), as well as any other suitable ingredients, are processedin the presence of a binder system during production or assembly of theoral product. In certain preferred embodiments, the binder systempossesses or exhibits thermoplastic properties, characteristics orbehaviors. See, e.g., the oral products and binder systems described inU.S. Pat. Pub. No. 2011/0220130 to Mua et al., which is hereinincorporated by reference in its entirety.

Oral Product Composition

The oral products described herein generally comprise a mixture that iscapable of being processed, extruded, and/or molded into a final shape.

Binding agents

The composition incorporates a binder system. The binder system may beemployed in certain embodiments, in amounts sufficient to provide thedesired physical attributes and physical integrity to the mixture.Binders also often function as thickening or gelling agents. The bindersystems disclosed herein include at least one type of binding agent thatexhibits thermoplastic properties, characteristics, or behaviors (e.g.,the binding agent can include at least one thermoplastic polymer, atleast one thermoplastic binding material, and/or at least oneplasticizing agent). In some embodiments, the binder system includesingredients or materials which in combination provide a binding agentthat exhibits thermoplastic characteristics. The amount of thermoplasticbinder system material employed within embodiments of the oral productsdescribed herein typically is at least about 5 percent, at least about10 percent, and often at least about 20 percent, of the final formedproduct, on a dry weight basis. The amount of thermoplastic bindersystem material employed within the mixtures described herein generallyis less than about 50 percent, and can be less than about 35 percent,less than about 30 percent, or less than about 25 percent of the finalformed product, on a dry weight basis. In some embodiments, the amountof binder system in the mixture can be present in an amount of about 5to about 50 weight percent, about 10 to about 45 weight percent, orabout 20 to about 40 weight percent, based on the total dry weight ofthe mixture.

The ingredient materials of the thermoplastic binder system can vary.The thermoplastic binder systems described herein include at least onethermoplastic polymer. The term thermoplastic as used herein refers to aproperty of an ingredient (e.g., a polymeric material) where uponheating, the ingredient softens or melts into a liquid that when cooled,hardens or forms a gel. For example, a polymeric material that comprisesthermoplastic properties, characteristics or behaviors softens or meltswhen exposed to heat, and then returns to its original physical type ofcondition when cooled (e.g., to about ambient temperature). As such, athermoplastic binding agent can be contacted with an active agent(s)and/or flavorant(s) and various other ingredients, mixed so as toprovide physical contact of the binding agent with those ingredients,heated so as to soften or liquefy the polymeric material of thethermoplastic binder system, and then cooled so as to harden thesoftened thermoplastic polymeric material (and hence result in an oralproduct that is formed from the ingredients and that has a desirablephysical integrity). For purposes of the present disclosure, desirablethermoplastic polymeric materials useful in the binder systems and oralproducts described herein generally soften or melt (and hence exhibitthermoplastic characteristics) at temperatures of about 50° C. orgreater, about 60° C. or greater, about 70° C. or greater, about 100° C.or greater, about 120° C. or greater, about 150° C. or greater, or about180° C. or greater. In various embodiments, the thermoplastic polymercan have a melting point of about 200° C. or less, about 300° C. orless, 250° C. or less, about 200° C. or less, about 160° C. or less,about 150° C. or less, about 140° C. or less, about 120° C. or less,about 100° C. or less, or about 90° C. or less. In some embodiments, thethermoplastic polymer can have a melting point in the range of about100° C. to about 350° C., or about 200° C. to about 300° C.

Example thermoplastic polymers include various polyolefin and polyestermaterials. In certain embodiments, the thermoplastic polymer of thebinder system can be a biodegradable polymer, such as an aliphaticpolyester. Example aliphatic polyesters include polyglycolic acid (PGA),polylactic acid (PLA) (e.g., poly(L-lactic acid) or poly(DL-lacticacid)), polyhydroxyalkanoates (PHAs) such as polyhydroxypropionate,polyhydroxyvalerate, polyhydroxybutyrate, polyhydroxyhexanoate, andpolyhydroxyoctanoate, polycaprolactone (PCL), polybutylene succinate,polybutylene succinate adipate, and copolymers thereof (e.g.,polyhydroxybutyrate-co-hydroxyvalerate (PHBV)). In some embodiments, thethermoplastic polymer can include polyethylene oxide, certain celluloseethers (e.g., hydroxypropyl cellulose, ethylcellulose and hydroxypropylmethylcellulose), polyvinyl alcohol and polyvinyl acetate.

In certain embodiments, the binder system can include a thermoplasticpolymer selected from the group consisting of polyvinyl polypyrrolidone,methylcellulose, maltodextrin, pullulan, certain modified starches andhigh molecular weight propylene glycols (e.g., propylene glycols havingmolecular weights above about 4000 Da), and combinations thereof. Incertain embodiments, the binder system includes a gum, for example, anatural gum. As used herein, a natural gum refers to polysaccharidematerials of natural origin that have binding properties, and which arealso useful as a thickening or gelling agents. Representative naturalgums derived from plants, which are typically water soluble to somedegree, include xanthan gum, guar gum, gum arabic, ghatti gum, gumtragacanth, karaya gum, locust bean gum, gellan gum, and combinationsthereof.

In various embodiments of the oral products described herein, athermoplastic polymer can be present in an amount of at least about 5percent, at least about 10 percent, or at least about 15 percent of thefinal formed product, on a dry weight basis. In some embodiments, theamount of thermoplastic polymeric material employed within arepresentative oral product generally is less than about 30 percent,less than about 25 percent, less than about 20 percent, or less thanabout 15 percent of the final formed product, on a dry weight basis.

The amount of thermoplastic binding materials employed within arepresentative processed oral product of the present disclosure can beat least about 5 percent, at least about 10 percent, or at least about15 percent of the final formed product, on a dry weight basis. Theamount of thermoplastic binding material employed within arepresentative processed oral product of the present disclosuregenerally can be about 40 percent or less, about 30 percent or less,about 25 percent or less, about 20 percent or less, or about 15 percentor less of the final formed product, on a dry weight basis.

The binder system can incorporate a compound that can be characterizedas a plasticizer. For example, the aforementioned thermoplastic bindingmaterials can be combined with, and processed in combination with, atleast one plasticizer. In some oral products, a binder system can beemployed with a plasticizer blend. In some embodiments, the plasticizerblend can be pre-mixed separate from the mixing with a binder system orother ingredients.

In various embodiments, the plasticizer can be organic non-polymericmaterials. For example, the plasticizer can include glycerin, propyleneglycol, polyethylene glycol, polypropylene glycol, and combinationsthereof. In certain embodiments, the plasticizer can comprise a mediumand/or high molecular weight polyol-type compounds. Some examplerepresentative polyols include maltitol, sorbitol, isomalt, erythritol,xylitol, mannitol, polyglycitol, and combinations thereof.

In some embodiments, the binder system can include a plasticizer blend.The plasticizer blend can comprise various polyols, such as maltitol,sorbitol, isomalt, erythritol, xylitol, mannitol, and polyglycitol;

glycerin; propylene glycol; polyethylene glycol; polypropylene glycol;and combinations thereof. In some plasticizer blends, a syrup or liquidform of a polyol can be employed, for example, maltitol syrup orsorbitol liquid. The syrup or liquid form of the polyol can include atleast 20 percent solids, at least 35 percent solids, at least 50 percentsolids, at least 60 percent solids, at least 70 percent solids, or atleast 75 percent solids.

The amount of plasticizer utilized within the oral product can vary.When employed, the amount of plasticizer present within a representativeoral product can be at least about 1 percent, at least about 2 percent,at least about 3 percent, at least about 5 percent, at least about 10percent, or at least about 15 percent of the final formed product, on adry weight basis. When employed, the amount of plasticizer employedwithin a representative processed oral product typically is about 50percent or less, about 35 percent or less, about 25 percent or less, 15percent or less, about 10 percent or less, or about 5 percent or less,of the final formed product, on a dry weight basis.

In some embodiments, the plasticizer (including blends thereof) can beprepared separately and then added to a premixed oral product mixtureincluding a binder system as described herein. The plasticizer can beprepared by mixing its granular components with water. The plasticizercan be heated for a period of time and stirred until the plasticizerblend exhibits clear, viscous liquid properties. In some embodiments,the plasticizer can be prepared without the mixing of its granularcomponents with water. By mixing and heating the plasticizer separatefrom the oral product mixture and binding system, the plasticizer can beheated to a higher temperature without concern of charring and/orscalding the other components of the oral product composition. Uponsubjecting the plasticizer to a higher temperature, the plasticizerblend can exhibit plastic-type or visco-elastic properties. Theviscosity of such a plasticizer at about 25° C. is typically less thanabout 25,000 centipoise (cp), and often less than about 15,000 cp. Whenemployed in an oral product, the viscosity of the plasticizer at about25° C. is about 100 cp or greater, or about 1500 cp or greater. Withoutbeing limited by theory, an oral product incorporating a plasticizerhaving such plastic-like or visco-elastic properties can provide achewable tobacco product that does not crumble or fall apart in a user'smouth upon light to moderate chewing. Such a chewable tobacco productcan change shape in the mouth when lightly to moderately chewed withoutdisintegrating into small particles.

The selection and amount of plasticizer(s) or plasticizer blend can besuch that the softening temperature of the thermoplastic bindingmaterial is lowered. For example, HPC (KLUCEL) a thermoplastic material,has a melting point of about 370° C., which is lowered to less than 250°C. in the presence of either the plasticizer propylene glycol (PG) orglycerol. HPMC (BENECEL E4M) has a melting point of about 200° C., whichis lowered to less than 150° C. in the presence of PG or glycerol. Theabove involve the inclusion of glycerol or PG at about 10-20% by weight.Without being limited by theory, the plasticizer can act to facilitatehydration, and hence facilitate liquification of the thermoplasticbinding material. As such, formation of the oral product at relativelylow temperatures can be facilitated (e.g., at a temperature lower thanthe normal melting point of the thermoplastic binding material). In thisway, the binder system within an oral formulation of the presentdisclosure can lower the operating temperature at which the oralformulation is formed, thereby reducing and/or avoiding the scaldingand/or charring of the other materials in the mixture. In addition, theplasticizer can reduce the need for large amounts of moisture, or otherliquid carrier materials, that in tum need to be boiled off throughdrying stages after formation of the oral product.

Thermoplastic polymeric materials, plasticizers, and mixtures of thesematerials can be processed at the processing and operating conditionsdescribed in more detail below. Such thermoplastic polymeric materialsand plasticizers typically exhibit thermoplastic characteristics attemperatures below about 140° C., below about 120° C., or below about100° C.

Active ingredient

The composition as disclosed herein includes one or more activeingredients. As used herein, an “active ingredient” refers to one ormore substances belonging to any of the following categories: API(active pharmaceutical ingredient), food additives, natural medicaments,and naturally occurring substances that can have an effect on humans.Example active ingredients include any ingredient known to impact one ormore biological functions within the body, such as ingredients thatfurnish pharmacological activity or other direct effect in thediagnosis, cure, mitigation, treatment, or prevention of disease, orwhich affect the structure or any function of the body of humans (e.g.,provide a stimulating action on the central nervous system, have anenergizing effect, an antipyretic or analgesic action, or an otherwiseuseful effect on the body). In some embodiments, the active ingredientmay be of the type generally referred to as dietary supplements,nutraceuticals, “phytochemicals” or “functional foods.” These types ofadditives are sometimes defined in the art as encompassing substancestypically available from naturally-occurring sources (e.g., botanicalmaterials) that provide one or more advantageous biological effects(e.g., health promotion, disease prevention, or other medicinalproperties), but are not classified or regulated as drugs.

Non-limiting examples of active ingredients include those falling in thecategories of botanical ingredients, stimulants, amino acids, nicotinecomponents, and/or pharmaceutical, nutraceutical, and medicinalingredients (e.g., vitamins, such as A, B3, B6, B12, and C, and/orcannabinoids, such as tetrahydrocannabinol (THC) and cannabidiol (CBD)).Each of these categories is further described herein below. Theparticular choice of active ingredients will vary depending upon thedesired flavor, texture, and desired characteristics of the particularproduct.

In certain embodiments, the active ingredient is selected from the groupconsisting of caffeine, taurine, GABA, theanine, vitamin C, lemon balmextract, ginseng, citicoline, sunflower lecithin, and combinationsthereof. For example, the active ingredient can include a combination ofcaffeine, theanine, and optionally ginseng. In another embodiment, theactive ingredient includes a combination of theanine, gamma-aminobutyric acid (GABA), and lemon balm extract. In a further embodiment,the active ingredient includes theanine, theanine and tryptophan, ortheanine and one or more B vitamins (e.g., vitamin B6 or B12). In astill further embodiment, the active ingredient includes a combinationof caffeine, taurine, and vitamin C.

The particular percentages of active ingredients present will varydepending upon the desired characteristics of the particular product.Typically, an active ingredient or combination thereof is present in atotal concentration of at least about 0.001% by weight of thecomposition, such as in a range from about 0.001% to about 20%. In someembodiments, the active ingredient or combination of active ingredientsis present in a concentration from about 0.1% w/w to about 10% byweight, such as, e.g., from about 0.5% w/w to about 10%, from about 1%to about 10%, from about 1% to about 5% by weight, based on the totalweight of the composition. In some embodiments, the active ingredient orcombination of active ingredients is present in a concentration of fromabout 0.001%, about 0.01%, about 0.1%, or about 1%, up to about 20% byweight, such as, e.g., from about 0.001%, about 0.002%, about 0.003%,about 0.004%, about 0.005%, about 0.006%, about 0.007%, about 0.008%,about 0.009%, about 0.01%, about 0.02%, about 0.03%, about 0.04%, about0.05%, about 0.06%, about 0.07%, about 0.08%, about 0.09%, about 0.1%,about 0.2%, about 0.3%, about 0.4%, about 0.5% about 0.6%, about 0.7%,about 0.8%, or about 0.9%, to about 1%, about 2%, about 3%, about 4%,about 5%, about 6%, about 7%, about 8%, about 9%, about 10%, about 11%,about 12%, about 13%, about 14%, about 15%, about 16%, about 17%, about18%, about 19%, or about 20% by weight, based on the total weight of thecomposition. Further suitable ranges for specific active ingredients areprovided herein below.

Botanical

In some embodiments, the active ingredient comprises a botanicalingredient. As used herein, the term “botanical ingredient” or“botanical” refers to any plant material or fungal-derived material,including plant material in its natural form and plant material derivedfrom natural plant materials, such as extracts or isolates from plantmaterials or treated plant materials (e.g., plant materials subjected toheat treatment, fermentation, bleaching, or other treatment processescapable of altering the physical and/or chemical nature of thematerial). For the purposes of the present disclosure, a “botanical”includes, but is not limited to, “herbal materials,” which refer toseed-producing plants that do not develop persistent woody tissue andare often valued for their medicinal or sensory characteristics (e.g.,teas or tisanes). Reference to botanical material as “non-tobacco” isintended to exclude tobacco materials (i.e., does not include anyNicotiana species). In some embodiments, the compositions as disclosedherein can be characterized as free of any tobacco material (e.g., anyembodiment as disclosed herein may be completely or substantially freeof any tobacco material). By “substantially free” is meant that notobacco material has been intentionally added. For example, certainembodiments can be characterized as having less than 0.001% by weight oftobacco, or less than 0.0001%, or even 0% by weight of tobacco.

When present, a botanical is typically at a concentration of from about0.01% w/w to about 10% by weight, such as, e.g., from about 0.01% w/w,about 0.05%, about 0.1%, or about 0.5%, to about 1%, about 2%, about 3%,about 4%, about 5%, about 6%, about 7%, about 8%, about 9%, or about10%, about 11%, about 12%, about 13%, about 14%, or about 15% by weight,based on the total weight of the composition.

The botanical materials useful in the present disclosure may comprise,without limitation, any of the compounds and sources set forth herein,including mixtures thereof. Certain botanical materials of this type aresometimes referred to as dietary supplements, nutraceuticals,“phytochemicals” or “functional foods.” Certain botanicals, as the plantmaterial or an extract thereof, have found use in traditional herbalmedicine, and are described further herein. Non-limiting examples ofbotanicals or botanical-derived materials include ashwagandha, Bacopamonniera, baobab, basil, Centella asiatica, Chai-hu, chamomile, cherryblossom, chlorophyll, cinnamon, citrus, cloves, cocoa, cordyceps,curcumin, damiana, Dorstenia arifolia, Dorstenia odorata, essentialoils, eucalyptus, fennel, Galphimia glauca, ginger, Ginkgo biloba,ginseng (e.g., Panax ginseng), green tea, Griffonia simplicifolia,guarana, cannabis, hemp, hops, jasmine, Kaempferia parviflora (Thaiginseng), kava, lavender, lemon balm, lemongrass, licorice, lutein,maca, matcha, Nardostachys chinensis, oil-based extract of Violaodorata, peppermint, quercetin, resveratrol, Rhizoma gastrodiae,Rhodiola, rooibos, rose essential oil, rosemary, Sceletium tortuosum,Schisandra, Skullcap, spearmint extract, Spikenard, terpenes, tisanes,turmeric, Turnera aphrodisiaca, valerian, white mulberry, and Yerbamate.

In some embodiments, the active ingredient comprises lemon balm. Lemonbalm (Melissa officinalis) is a mildly lemon-scented herb from the samefamily as mint (Lamiaceae). The herb is native to Europe, North Africa,and West Asia. The tea of lemon balm, as well as the essential oil andthe extract, are used in traditional and alternative medicine. In someembodiments, the active ingredient comprises lemon balm extract. In someembodiments, the lemon balm extract is present in an amount of fromabout 1 to about 4% by weight, based on the total weight of thecomposition.

In some embodiments, the active ingredient comprises ginseng. Ginseng isthe root of plants of the genus Panax, which are characterized by thepresence of unique steroid saponin phytochemicals (ginsenosides) andgintonin. Ginseng finds use as a dietary supplement in energy drinks orherbal teas, and in traditional medicine. Cultivated species includeKorean ginseng (P. ginseng), South China ginseng (P. notoginseng), andAmerican ginseng (P. quinquefolius). American ginseng and Korean ginsengvary in the type and quantity of various ginsenosides present. In someembodiments, the ginseng is American ginseng or Korean ginseng. Inspecific embodiments, the active ingredient comprises Korean ginseng. Insome embodiments, ginseng is present in an amount of from about 0.4 toabout 0.6% by weight, based on the total weight of the composition.

Stimulants

In some embodiments, the active ingredient comprises one or morestimulants. As used herein, the term “stimulant” refers to a materialthat increases activity of the central nervous system and/or the body,for example, enhancing focus, cognition, vigor, mood, alertness, and thelike. Non-limiting examples of stimulants include caffeine, theacrine,theobromine, and theophylline. Theacrine (1,3,7,9-tetramethyluric acid)is a purine alkaloid which is structurally related to caffeine, andpossesses stimulant, analgesic, and anti-inflammatory effects. Presentstimulants may be natural, naturally derived, or wholly synthetic. Forexample, certain botanical materials (guarana, tea, coffee, cocoa, andthe like) may possess a stimulant effect by virtue of the presence ofe.g., caffeine or related alkaloids, and accordingly are “natural”stimulants. By “naturally derived” is meant the stimulant (e.g.,caffeine, theacrine) is in a purified form, outside its natural (e.g.,botanical) matrix. For example, caffeine can be obtained by extractionand purification from botanical sources (e.g., tea). By “whollysynthetic”, it is meant that the stimulant has been obtained by chemicalsynthesis. In some embodiments, the active ingredient comprisescaffeine. In some embodiments, the caffeine is present in anencapsulated form. On example of an encapsulated caffeine is Vitashure®,available from Balchem Corp., 52 Sunrise Park Road, New Hampton, N.Y.,10958.

When present, a stimulant or combination of stimulants (e.g., caffeine,theacrine, and combinations thereof) is typically at a concentration offrom about 0.1% w/w to about 15% by weight, such as, e.g., from about0.1% w/w, about 0.2%, about 0.3%, about 0.4%, about 0.5% about 0.6%,about 0.7%, about 0.8%, or about 0.9%, to about 1%, about 2%, about 3%,about 4%, about 5%, about 6%, about 7%, about 8%, about 9%, about 10%,about 11%, about 12%, about 13%, about 14%, or about 15% by weight,based on the total weight of the composition. In some embodiments, thecomposition comprises caffeine in an amount of from about 1.5 to about6% by weight, based on the total weight of the composition;

Amino Acids

In some embodiments, the active ingredient comprises an amino acid. Asused herein, the term “amino acid” refers to an organic compound thatcontains amine (—NH2) and carboxyl (—COOH) or sulfonic acid (SO₃H)functional groups, along with a side chain (R group), which is specificto each amino acid. Amino acids may be proteinogenic ornon-proteinogenic. By “proteinogenic” is meant that the amino acid isone of the twenty naturally occurring amino acids found in proteins. Theproteinogenic amino acids include alanine, arginine, asparagine,aspartic acid, cysteine, glutamine, glutamic acid, glycine, histidine,isoleucine, leucine, lysine, methionine, phenylalanine, proline, serine,threonine, tryptophan, tyrosine, and valine. By “non-proteinogenic” ismeant that either the amino acid is not found naturally in protein, oris not directly produced by cellular machinery (e.g., is the product ofpost-tranlational modification). Non-limiting examples ofnon-proteinogenic amino acids include gamma-aminobutyric acid (GABA),taurine (2-aminoethanesulfonic acid), theanine (L-γ-glutamylethylamide),hydroxyproline, and beta-alanine. In some embodiments, the activeingredient comprises theanine. In some embodiments, the activeingredient comprises GABA. In some embodiments, the active ingredientcomprises a combination of theanine and GABA. In some embodiments, theactive ingredient is a combination of theanine, GABA, and lemon balm.

In some embodiments, the active ingredient is a combination of caffeine,theanine, and ginseng. In some embodiments, the active ingredientcomprises taurine. In some embodiments, the active ingredient is acombination of caffeine and taurine.

When present, an amino acid or combination of amino acids (e.g.,theanine, GABA, and combinations thereof) is typically at aconcentration of from about 0.1% w/w to about 15% by weight, such as,e.g., from about 0.1% w/w, about 0.2%, about 0.3%, about 0.4%, about0.5% about 0.6%, about 0.7%, about 0.8%, or about 0.9%, to about 1%,about 2%, about 3%, about 4%, about 5%, about 6%, about 7%, about 8%,about 9%, about 10%, about 11%, about 12%, about 13%, about 14%, orabout 15% by weight, based on the total weight of the composition.

Vitamins

In some embodiments, the active ingredient comprises a vitamin orcombination of vitamins. As used herein, the term “vitamin” refers to anorganic molecule (or related set of molecules) that is an essentialmicronutrient needed for the proper functioning of metabolism in amammal. There are thirteen vitamins required by human metabolism, whichare: vitamin A (as all-trans-retinol, all-trans-retinol-esters, as wellas all-trans-beta-carotene and other provitamin A carotenoids), vitaminB1 (thiamine), vitamin B2 (riboflavin), vitamin B3 (niacin), vitamin B5(pantothenic acid), vitamin B6 (pyridoxine), vitamin B7 (biotin),vitamin B9 (folic acid or folate), vitamin B12 (cobalamins), vitamin C(ascorbic acid), vitamin D (calciferols), vitamin E (tocopherols andtocotrienols), and vitamin K (quinones). In some embodiments, the activeingredient comprises vitamin C In some embodiments, the activeingredient is a combination of vitamin C, caffeine, and taurine.

When present, a vitamin or combination of vitamins (e.g., vitamin B6,vitamin B12, vitamin E, vitamin C, or a combination thereof) istypically at a concentration of from about 0.01% w/w to about 6% byweight, such as, e.g., from about 0.01%, about 0.02%, about 0.03%, about0.04%, about 0.05%, about 0.06%, about 0.07%, about 0.08%, about 0.09%,or about 0.1% w/w, to about 0.2%, about 0.3%, about 0.4%, about 0.5%about 0.6%, about 0.7%, about 0.8%, about 0.9%, about 1%, about 2%,about 3%, about 4%, about 5%, or about 6% by weight, based on the totalweight of the composition.

Antioxidants

In some embodiments, the active ingredient comprises one or moreantioxidants. As used herein, the term “antioxidant” refers to asubstance which prevents or suppresses oxidation by terminating freeradical reactions, and may delay or prevent some types of cellulardamage. Antioxidants may be naturally occurring or synthetic. Naturallyoccurring antioxidants include those found in foods and botanicalmaterials. Non-limiting examples of antioxidants include certainbotanical materials, vitamins, polyphenols, and phenol derivatives.

Examples of botanical materials which are associated with antioxidantcharacteristics include without limitation acai berry, alfalfa,allspice, annatto seed, apricot oil, basil, bee balm, wild bergamot,black pepper, blueberries, borage seed oil, bugleweed, cacao, calamusroot, catnip, catuaba, cayenne pepper, chaga mushroom, chervil,cinnamon, dark chocolate, potato peel, grape seed, ginseng, gingkobiloba, Saint John's Wort, saw palmetto, green tea, black tea, blackcohosh, cayenne, chamomile, cloves, cocoa powder, cranberry, dandelion,grapefruit, honeybush, echinacea, garlic, evening primrose, feverfew,ginger, goldenseal, hawthorn, hibiscus flower, jiaogulan, kava,lavender, licorice, marjoram, milk thistle, mints (menthe), oolong tea,beet root, orange, oregano, papaya, pennyroyal, peppermint, red clover,rooibos (red or green), rosehip, rosemary, sage, clary sage, savory,spearmint, spirulina, slippery elm bark, sorghum bran hi-tannin, sorghumgrain hi-tannin, sumac bran, comfrey leaf and root, goji berries, gutukola, thyme, turmeric, uva ursi, valerian, wild yam root, wintergreen,yacon root, yellow dock, yerba mate, yerba santa, bacopa monniera,withania somnifera, Lion's mane, and silybum marianum. Such botanicalmaterials may be provided in fresh or dry form, essential oils, or maybe in the form of an extracts. The botanical materials (as well as theirextracts) often include compounds from various classes known to provideantioxidant effects, such as minerals, vitamins, isoflavones,phytoesterols, allyl sulfides, dithiolthiones, isothiocyanates, indoles,lignans, flavonoids, polyphenols, and carotenoids. Examples of compoundsfound in botanical extracts or oils include ascorbic acid, peanutendocarb, resveratrol, sulforaphane, beta-carotene, lycopene, lutein,co-enzyme Q, carnitine, quercetin, kaempferol, and the like. See, e.g.,Santhosh et al., Phytomedicine, 12(2005) 216-220, which is incorporatedherein by reference.

Non-limiting examples of other suitable antioxidants include citricacid, Vitamin E or a derivative thereof, a tocopherol, epicatechol,epigallocatechol, epigallocatechol gallate, erythorbic acid, sodiumerythorbate, 4-hexylresorcinol, theaflavin, theaflavin monogallate A orB, theaflavin digallate, phenolic acids, glycosides, quercitrin,isoquercitrin, hyperoside, polyphenols, catechols, resveratrols,oleuropein, butylated hydroxyanisole (BHA), butylated hydroxytoluene(BHT), tertiary butylhydroquinone (TBHQ), and combinations thereof.

When present, an antioxidant is typically at a concentration of fromabout 0.001% w/w to about 10% by weight, such as, e.g., from about0.001%, about 0.005%, about 0.01% w/w, about 0.05%, about 0.1%, or about0.5%, to about 1%, about 2%, about 3%, about 4%, about 5%, about 6%,about 7%, about 8%, about 9%, or about 10%, based on the total weight ofthe composition.

Nicotine Component

In certain embodiments, the products of the present disclosure caninclude a nicotinic compound. Various nicotinic compounds, and methodsfor their administration, are set forth in US Pat. Pub. No. 2011/0274628to Borschke, which is incorporated herein by reference. As used herein,“nicotinic compound” or “source of nicotine” often refers tonaturally-occurring or synthetic nicotinic compound unbound from a plantmaterial, meaning the compound is at least partially purified and notcontained within a plant structure, such as a tobacco leaf. Mostpreferably, nicotine is naturally-occurring and obtained as an extractfrom a Nicotiana species (e.g., tobacco). The nicotine can have theenantiomeric form S(−)-nicotine,

R(+)-nicotine, or a mixture of S(−)-nicotine and R(+)-nicotine. Mostpreferably, the nicotine is in the form of S(−)-nicotine (e.g., in aform that is virtually all S(−)-nicotine) or a racemic mixture composedprimarily or predominantly of S(−)-nicotine (e.g., a mixture composed ofabout 95 weight parts S(−)-nicotine and about 5 weight partsR(+)-nicotine). Most preferably, the nicotine is employed in virtuallypure form or in an essentially pure form. Highly preferred nicotine thatis employed has a purity of greater than about 95 percent, morepreferably greater than about 98 percent, and most preferably greaterthan about 99 percent, on a weight basis.

In certain embodiments, a nicotine component may be included in themixture in free base form, salt form, as a complex, or as a solvate. By“nicotine component” is meant any suitable form of nicotine (e.g., freebase or salt) for providing oral absorption of at least a portion of thenicotine present. Typically, the nicotine component is selected from thegroup consisting of nicotine free base and a nicotine salt. In someembodiments, nicotine is in its free base form, which easily can beadsorbed in for example, a microcrystalline cellulose material to form amicrocrystalline cellulose-nicotine carrier complex. See, for example,the discussion of nicotine in free base form in US Pat. Pub. No.2004/0191322 to Hansson, which is incorporated herein by reference.

In some embodiments, at least a portion of the nicotine can be employedin the form of a salt. Salts of nicotine can be provided using the typesof ingredients and techniques set forth in US Pat. No. 2,033,909 to Coxet al. and Perfetti, Beitrage Tabakforschung Int., 12: 43-54 (1983),which are incorporated herein by reference. Additionally, salts ofnicotine are available from sources such as Pfaltz and Bauer, Inc. andK&K Laboratories, Division of ICN Biochemicals, Inc. Typically, thenicotine component is selected from the group consisting of nicotinefree base, a nicotine salt such as hydrochloride, dihydrochloride,monotartrate, bitartrate, sulfate, salicylate, and nicotine zincchloride. In some embodiments, the nicotine component or a portionthereof is a nicotine salt with one or more organic acids.

In some embodiments, at least a portion of the nicotine can be in theform of a resin complex of nicotine, where nicotine is bound in anion-exchange resin, such as nicotine polacrilex, which is nicotine boundto, for example, a polymethacrilic acid, such as Amberlite IRP64,Purolite C115HMR, or Doshion P551. See, for example, U.S. Pat. No.3,901,248 to Lichtneckert et al., which is incorporated herein byreference. Another example is a nicotine-polyacrylic carbomer complex,such as with Carbopol 974P. In some embodiments, nicotine may be presentin the form of a nicotine polyacrylic complex.

Typically, the nicotine component (calculated as the free base) whenpresent, is in a concentration of at least about 0.001% by weight of themixture, such as in a range from about 0.001% to about 10%. In someembodiments, the nicotine component is present in a concentration fromabout 0.1% w/w to about 10% by weight, such as, e.g., from about 0.1%w/w, about 0.2%, about 0.3%, about 0.4%, about 0.5% about 0.6%, about0.7%, about 0.8%, or about 0.9%, to about 1%, about 2%, about 3%, about4%, about 5%, about 6%, about 7%, about 8%, about 9%, or about 10% byweight, calculated as the free base and based on the total weight of themixture. In some embodiments, the nicotine component is present in aconcentration from about 0.1% w/w to about 3% by weight, such as, e.g.,from about 0.1% w/w to about 2.5%, from about 0.1% to about 2.0%, fromabout 0.1% to about 1.5%, or from about 0.1% to about 1% by weight,calculated as the free base and based on the total weight of themixture. These ranges can also apply to other active ingredients notedherein.

In some embodiments, the products or compositions of the disclosure canbe characterized as free of any nicotine component (e.g., any embodimentas disclosed herein may be completely or substantially free of anynicotine component). By “substantially free” is meant that no nicotinehas been intentionally added, beyond trace amounts that may be naturallypresent in e.g., a botanical material. For example, certain embodimentscan be characterized as having less than 0.001% by weight of nicotine,or less than 0.0001%, or even 0% by weight of nicotine, calculated asthe free base.

In some embodiments, the active ingredient comprises a nicotinecomponent (e.g., any product or composition of the disclosure, inaddition to comprising any active ingredient or combination of activeingredients as disclosed herein, may further comprise a nicotinecomponent).

Cannabinoids

In some embodiments, the active ingredient comprises one or morecannabinoids. As used herein, the term “cannabinoid” refers to a classof diverse chemical compounds that acts on cannabinoid receptors, alsoknown as the endocannabinoid system, in cells that alterneurotransmitter release in the brain. Ligands for these receptorproteins include the endocannabinoids produced naturally in the body byanimals; phytocannabinoids, found in cannabis; and syntheticcannabinoids, manufactured artificially. Cannabinoids found in cannabisinclude, without limitation: cannabigerol (CBG), cannabichromene (CBC),cannabidiol (CBD), tetrahydrocannabinol (THC), cannabinol (CBN),cannabinodiol (CBDL), cannabicyclol (CBL), cannabivarin (CBV),tetrahydrocannabivarin (THCV), cannabidivarin (CBDV), cannabichromevarin(CBCV), cannabigerovarin (CBGV), cannabigerol monomethyl ether (CBGM),cannabinerolic acid, cannabidiolic acid (CBDA), cannabinol propylvariant (CBNV), cannabitriol (CBO), tetrahydrocannabinolic acid (THCA),and tetrahydrocannabivarinic acid (THCV A). In certain embodiments, thecannabinoid is selected from tetrahydrocannabinol (THC), the primarypsychoactive compound in cannabis, and cannabidiol (CBD) another majorconstituent of the plant, but which is devoid of psychoactivity. All ofthe above compounds can be used in the form of an isolate from plantmaterial or synthetically derived. Alternatively, the active ingredientcan be a cannabimimetic, which is a class of compounds derived fromplants other than cannabis that have biological effects on theendocannabinoid system similar to cannabinoids. Examples includeyangonin, alpha-amyrin or beta-amyrin (also classified as terpenes),cyanidin, curcumin (tumeric), catechin, quercetin, salvinorin A,N-acylethanolamines, and N-alkylamide lipids.

When present, a cannabinoid (e.g., CBD) or cannabimimetic is typicallyin a concentration of at least about 0.1% by weight of the composition,such as in a range from about 0.1% to about 30%, such as, e.g., fromabout 0.1%, about 0.2%, about 0.3%, about 0.4%, about 0.5% about 0.6%,about 0.7%, about 0.8%, or about 0.9%, to about 1%, about 2%, about 3%,about 4%, about 5%, about 6%, about 7%, about 8%, about 9%, about 10%,about 15%, about 20%, or about 30% by weight, based on the total weightof the composition.

Terpenes

Active ingredients suitable for use in the present disclosure can alsobe classified as terpenes, many of which are associated with biologicaleffects, such as calming effects. Terpenes are understood to have thegeneral formula of (C₅H₈)_(n) and include monoterpenes, sesquiterpenes,and diterpenes. Terpenes can be acyclic, monocyclic or bicyclic instructure. Some terpenes provide an entourage effect when used incombination with cannabinoids or cannabimimetics. Examples includebeta-caryophyllene, linalool, limonene, beta-citronellol, linalylacetate, pinene (alpha or beta), geraniol, carvone, eucalyptol,menthone, iso-menthone, piperitone, myrcene, beta-bourbonene, andgermacrene, which may be used singly or in combination.

Pharmaceutical Ingredients

In some embodiments, the active ingredient comprises an activepharmaceutical ingredient (API). The API can be any known agent adaptedfor therapeutic, prophylactic, or diagnostic use. These can include, forexample, synthetic organic compounds, proteins and peptides,polysaccharides and other sugars, lipids, phospholipids, inorganiccompounds (e.g., magnesium, selenium, zinc, nitrate), neurotransmittersor precursors thereof (e.g., serotonin, 5-hydroxytryptophan, oxitriptan,acetylcholine, dopamine, melatonin), and nucleic acid sequences, havingtherapeutic, prophylactic, or diagnostic activity. Non-limiting examplesof APIs include analgesics and antipyretics (e.g., acetylsalicylic acid,acetaminophen, 3-(4-isobutylphenyl)propanoic acid), phosphatidylserine,myoinositol, docosahexaenoic acid (DHA, Omega-3), arachidonic acid (AA,Omega-6), S-adenosylmethionine (SAM), beta-hydroxy-beta-methylbutyrate(HMB), citicoline (cytidine-5′-diphosphate-choline), and cotinine. Insome embodiments, the active ingredient comprises citicoline. In someembodiments, the active ingredient is a combination of citicoline,caffeine, theanine, and ginseng. In some embodiments, the activeingredient comprises sunflower lecithin. In some embodiments, the activeingredient is a combination of sunflower lecithin, caffeine, theanine,and ginseng.

The amount of API may vary. For example, when present, an API istypically at a concentration of from about 0.001% w/w to about 10% byweight, such as, e.g., from about 0.01%, about 0.02%, about 0.03%, about0.04%, about 0.05%, about 0.06%, about 0.07%, about 0.08%, about 0.09%,about 0.1% w/w, about 0.2%, about 0.3%, about 0.4%, about 0.5% about0.6%, about 0.7%, about 0.8%, about 0.9%, or about 1%, to about 2%,about 3%, about 4%, about 5%, about 6%, about 7%, about 8%, about 9%, orabout 10% by weight, based on the total weight of the composition.

In some embodiments, the composition is substantially free of any API.By “substantially free of any API” means that the composition does notcontain, and specifically excludes, the presence of any API as definedherein, such as any Food and Drug Administration (FDA) approvedtherapeutic agent intended to treat any medical condition.

Tobacco Material

In some embodiments, the mixture may include a tobacco material. Thetobacco material can vary in species, type, and form. Generally, thetobacco material is obtained from for a harvested plant of the Nicotianaspecies. Example Nicotiana species include N. tabacum, N. rustica, N.alata, N. arentsii, N. excelsior, N. forgetiana, N. glauca, N.glutinosa, N. gossei, N. kawakamii, N. knightiana, N. langsdorffi, N.otophora, N. setchelli, N. sylvestris, N. tomentosa, N. tomentosiformis,N. undulata, N. x sanderae, N. africana, N. amplexicaulis, N.benavidesii, N. bonariensis, N. debneyi, N. longiflora, N. maritina, N.megalosiphon, N. occidentalis, N. paniculata, N. plumbaginifolia, N.raimondii, N. rosulata, N. simulans, N. stocktonii, N. suaveolens, N.umbratica, N. velutina, N. wigandioides, N. acaulis, N. acuminata, N.attenuata, N. benthamiana, N. cavicola, N. clevelandii, N. cordifolia,N. corymbosa, N. fragrans, N. goodspeedii, N. linearis, N. miersii, N.nudicaulis, N. obtusifolia, N. occidentalis subsp. Hersperis, N.pauciflora, N. petunioides, N. quadrivalvis, N. repanda, N.rotundifolia, N. solanifolia, and N. spegazzinii. Various representativeother types of plants from the Nicotiana species are set forth inGoodspeed, The Genus Nicotiana, (Chonica Botanica) (1954); U.S. Pat. No.4,660,577 to Sensabaugh, Jr. et al.; U.S. Pat. No. 5,387,416 to White etal., U.S. Pat. No. 7,025,066 to Lawson et al.; U.S. Pat. No. 7,798,153to Lawrence, Jr. and U.S. Pat. No. 8,186,360 to Marshall et al.; each ofwhich is incorporated herein by reference. Descriptions of various typesof tobaccos, growing practices and harvesting practices are set forth inTobacco Production, Chemistry and Technology, Davis et al. (Eds.)(1999), which is incorporated herein by reference.

Nicotiana species from which suitable tobacco materials can be obtainedcan be derived using genetic-modification or crossbreeding techniques(e.g., tobacco plants can be genetically engineered or crossbred toincrease or decrease production of components, characteristics orattributes). See, for example, the types of genetic modifications ofplants set forth in U.S. Pat. No. 5,539,093 to Fitzmaurice et al.; U.S.Pat. No. 5,668,295 to Wahab et al.; U.S. Pat. No. 5,705,624 toFitzmaurice et al.; U.S. Pat. No. 5,844,119 to Weigl; U.S. Pat. No.6,730,832 to Dominguez et al.; U.S. Pat. No. 7,173,170 to Liu et al.;U.S. Pat. No. 7,208,659 to Colliver et al. and U.S. Pat. No. 7,230,160to Benning et al.; US Patent Appl. Pub. No. 2006/0236434 to Conkling etal.; and PCT WO2008/103935 to Nielsen et al. See, also, the types oftobaccos that are set forth in U.S. Pat. No. 4,660,577 to Sensabaugh,Jr. et al.; U.S. Pat. No. 5,387,416 to White et al.; and U.S. Pat. No.6,730,832 to Dominguez et al., each of which is incorporated herein byreference.

The Nicotiana species can, in some embodiments, be selected for thecontent of various compounds that are present therein. For example,plants can be selected on the basis that those plants produce relativelyhigh quantities of one or more of the compounds desired to be isolatedtherefrom. In certain embodiments, plants of the Nicotiana species(e.g., Galpao commun tobacco) are specifically grown for their abundanceof leaf surface compounds. Tobacco plants can be grown in greenhouses,growth chambers, or outdoors in fields, or grown hydroponically.

Various parts or portions of the plant of the Nicotiana species can beincluded within a mixture as disclosed herein. For example, virtuallyall of the plant (e.g., the whole plant) can be harvested, and employedas such. Alternatively, various parts or pieces of the plant can beharvested or separated for further use after harvest. For example, theflower, leaves, stem, stalk, roots, seeds, and various combinationsthereof, can be isolated for further use or treatment. In someembodiments, the tobacco material comprises tobacco leaf (lamina). Themixture disclosed herein can include processed tobacco parts or pieces,cured and aged tobacco in essentially natural lamina and/or stem form, atobacco extract, extracted tobacco pulp (e.g., using water as asolvent), or a mixture of the foregoing (e.g., a mixture that combinesextracted tobacco pulp with granulated cured and aged natural tobaccolamina).

In certain embodiments, the tobacco material comprises solid tobaccomaterial selected from the group consisting of lamina and stems. Thetobacco that is used for the mixture most preferably includes tobaccolamina, or a tobacco lamina and stem mixture (of which at least aportion is smoke-treated). Portions of the tobaccos within the mixturemay have processed forms, such as processed tobacco stems (e.g.,cut-rolled stems, cut-rolled-expanded stems or cut-puffed stems), orvolume expanded tobacco (e.g., puffed tobacco, such as dry ice expandedtobacco (DIET)). See, for example, the tobacco expansion processes setforth in U.S. Pat. No. 4,340,073 to de la Burde et al.; U.S. Pat. No.5,259,403 to Guy et al.; and U.S. Pat. No. 5,908,032 to Poindexter, etal.; and U.S. Pat. No. 7,556,047 to Poindexter, et al., all of which areincorporated by reference. In addition, the d mixture optionally mayincorporate tobacco that has been fermented. See, also, the types oftobacco processing techniques set forth in PCT WO2005/063060 to Atchleyet al., which is incorporated herein by reference.

The tobacco material is typically used in a form that can be describedas particulate (i.e., shredded, ground, granulated, or powder form). Themanner by which the tobacco material is provided in a finely divided orpowder type of form may vary. Preferably, plant parts or pieces arecomminuted, ground or pulverized into a particulate form using equipmentand techniques for grinding, milling, or the like. Most preferably, theplant material is relatively dry in form during grinding or milling,using equipment such as hammer mills, cutter heads, air control mills,or the like. For example, tobacco parts or pieces may be ground ormilled when the moisture content thereof is less than about 15 weightpercent or less than about 5 weight percent. Most preferably, thetobacco material is employed in the form of parts or pieces that have anaverage particle size between 1.4 millimeters and 250 microns. In someinstances, the tobacco particles may be sized to pass through a screenmesh to obtain the particle size range required. If desired, airclassification equipment may be used to ensure that small sized tobaccoparticles of the desired sizes, or range of sizes, may be collected. Ifdesired, differently sized pieces of granulated tobacco may be mixedtogether.

The manner by which the tobacco is provided in a finely divided orpowder type of form may vary. Preferably, tobacco parts or pieces arecomminuted, ground or pulverized into a powder type of form usingequipment and techniques for grinding, milling, or the like. Mostpreferably, the tobacco is relatively dry in form during grinding ormilling, using equipment such as hammer mills, cutter heads, air controlmills, or the like. For example, tobacco parts or pieces may be groundor milled when the moisture content thereof is less than about 15 weightpercent to less than about 5 weight percent. For example, the tobaccoplant or portion thereof can be separated into individual parts orpieces (e.g., the leaves can be removed from the stems, and/or the stemsand leaves can be removed from the stalk). The harvested plant orindividual parts or pieces can be further subdivided into parts orpieces (e.g., the leaves can be shredded, cut, comminuted, pulverized,milled or ground into pieces or parts that can be characterized asfiller-type pieces, granules, particulates or fine powders). The plant,or parts thereof, can be subjected to external forces or pressure (e.g.,by being pressed or subjected to roll treatment). When carrying out suchprocessing conditions, the plant or portion thereof can have a moisturecontent that approximates its natural moisture content (e.g., itsmoisture content immediately upon harvest), a moisture content achievedby adding moisture to the plant or portion thereof, or a moisturecontent that results from the drying of the plant or portion thereof.For example, powdered, pulverized, ground or milled pieces of plants orportions thereof can have moisture contents of less than about 25 weightpercent, often less than about 20 weight percent, and frequently lessthan about 15 weight percent.

For the preparation of oral products, it is typical for a harvestedplant of the Nicotiana species to be subjected to a curing process. Thetobacco materials incorporated within the mixture for inclusion withinproducts as disclosed herein are those that have been appropriatelycured and/or aged. Descriptions of various types of curing processes forvarious types of tobaccos are set forth in Tobacco Production, Chemistryand Technology, Davis et al. (Eds.) (1999). Examples of techniques andconditions for curing flue-cured tobacco are set forth in Nestor et al.,Beitrage Tabakforsch. Int., 20, 467-475 (2003) and U.S. Pat. No.6,895,974 to Peele, which are incorporated herein by reference.Representative techniques and conditions for air curing tobacco are setforth in U.S. Pat. No. 7,650,892 to Groves et al.; Roton et al.,Beitrage Tabakforsch. Int., 21, 305-320 (2005) and Staaf et al.,Beitrage Tabakforsch. Int., 21, 321-330 (2005), which are incorporatedherein by reference. Certain types of tobaccos can be subjected toalternative types of curing processes, such as fire curing or suncuring.

In certain embodiments, tobacco materials that can be employed includeflue-cured or Virginia (e.g., K326), burley, sun-cured (e.g., IndianKurnool and Oriental tobaccos, including Katerini, Prelip, Komotini,Xanthi and Yambol tobaccos), Maryland, dark, dark-fired, dark air cured(e.g., Madole, Passanda,

Cubano, Jatin and Bezuki tobaccos), light air cured (e.g., NorthWisconsin and Galpao tobaccos), Indian air cured, Red Russian andRustica tobaccos, as well as various other rare or specialty tobaccosand various blends of any of the foregoing tobaccos.

The tobacco material may also have a so-called “blended” form. Forexample, the tobacco material may include a mixture of parts or piecesof flue-cured, burley (e.g., Malawi burley tobacco) and Orientaltobaccos (e.g., as tobacco composed of, or derived from, tobacco lamina,or a mixture of tobacco lamina and tobacco stem). For example, arepresentative blend may incorporate about 30 to about 70 parts burleytobacco (e.g., lamina, or lamina and stem), and about 30 to about 70parts flue cured tobacco (e.g., stem, lamina, or lamina and stem) on adry weight basis. Other example tobacco blends incorporate about 75parts flue-cured tobacco, about 15 parts burley tobacco, and about 10parts Oriental tobacco; or about 65 parts flue-cured tobacco, about 25parts burley tobacco, and about 10 parts Oriental tobacco; or about 65parts flue-cured tobacco, about 10 parts burley tobacco, and about 25parts Oriental tobacco; on a dry weight basis. Other example tobaccoblends incorporate about 20 to about 30 parts Oriental tobacco and about70 to about 80 parts flue-cured tobacco on a dry weight basis.

Tobacco materials used in the present disclosure can be subjected to,for example, fermentation, bleaching, and the like. If desired, thetobacco materials can be, for example, irradiated, pasteurized, orotherwise subjected to controlled heat treatment. Such treatmentprocesses are detailed, for example, in U.S. Pat. No. 8,061,362 to Muaet al., which is incorporated herein by reference. In certainembodiments, tobacco materials can be treated with water and an additivecapable of inhibiting reaction of asparagine to form acrylamide uponheating of the tobacco material (e.g., an additive selected from thegroup consisting of lysine, glycine, histidine, alanine, methionine,cysteine, glutamic acid, aspartic acid, proline, phenylalanine, valine,arginine, compositions incorporating di- and trivalent cations,asparaginase, certain non-reducing saccharides, certain reducing agents,phenolic compounds, certain compounds having at least one free thiolgroup or functionality, oxidizing agents, oxidation catalysts, naturalplant extracts (e.g., rosemary extract), and combinations thereof. See,for example, the types of treatment processes described in U.S. Pat.Nos. 8,434,496, 8,944,072, and 8,991,403 to Chen et al., which are allincorporated herein by reference. In certain embodiments, this type oftreatment is useful where the original tobacco material is subjected toheat in the processes previously described.

In some embodiments, the type of tobacco material is selected such thatit is initially visually lighter in color than other tobacco materialsto some degree (e.g., whitened or bleached). In certain embodiments, theoral products described herein are substantially free of unbleachedtobacco material. Tobacco pulp can be whitened in certain embodimentsaccording to any means known in the art. For example, bleached tobaccomaterial produced by various whitening methods using various bleachingor oxidizing agents and oxidation catalysts can be used. Exampleoxidizing agents include peroxides (e.g., hydrogen peroxide), chloritesalts, chlorate salts, perchlorate salts, hypochlorite salts, ozone,ammonia, potassium permanganate, and combinations thereof. Exampleoxidation catalysts are titanium dioxide, manganese dioxide, andcombinations thereof. Processes for treating tobacco with bleachingagents are discussed, for example, in U.S. Pat. No. 787,611 to Daniels,Jr.; U.S. Pat. No. 1,086,306 to Oelenheinz; U.S. Pat. No. 1,437,095 toDelling; U.S. Pat. No. 1,757,477 to Rosenhoch; U.S. Pat. No. 2,122,421to Hawkinson; U.S. Pat. No. 2,148,147 to Baier; U.S. Pat. No. 2,170,107to Baier; U.S. Pat. No. 2,274,649 to Baier; U.S. Pat. No. 2,770,239 toPrats et al.; U.S. Pat. No. 3,612,065 to Rosen; U.S. Pat. No. 3,851,653to Rosen; U.S. Pat. No. 3,889,689 to Rosen; U.S. Pat. No. 3,943,940 toMinami; U.S. Pat. No. 3,943,945 to Rosen; U.S. Pat. No. 4,143,666 toRainer; U.S. Pat. No. 4,194,514 to Campbell; U.S. Pat. Nos. 4,366,823,4,366,824, and 4,388,933 to Rainer et al.; U.S. Pat. No. 4,641,667 toSchmekel et al.; U.S. Pat. No. 5,713,376 to Berger; U.S. Pat. No.9,339,058 to Byrd Jr. et al.; U.S. Pat. No. 9,420,825 to Beeson et al.;and U.S. Pat. No. 9,950,858 to Byrd Jr. et al.; as well as in US Pat.App. Pub. Nos. 2012/0067361 to Bjorkholm et al.; 2016/0073686 to Crooks;2017/0020183 to Bjorkholm; and 2017/0112183 to Bjorkholm, and in PCTPubl. Appl. Nos. WO1996/031255 to Giolvas and WO2018/083114 toBjorkholm, all of which are incorporated herein by reference. See also,e.g., U.S. patent application Ser. No. 16/226,742 to Mclanahan et al.,filed Dec. 20, 2018, which is herein incorporated by reference in itsentirety.

In some embodiments, the whitened tobacco material can have an ISObrightness of at least about 50%, at least about 60%, at least about65%, at least about 70%, at least about 75%, or at least about 80%. Insome embodiments, the whitened tobacco material can have an ISObrightness in the range of about 50% to about 90%, about 55% to about75%, or about 60% to about 70%. ISO brightness can be measured accordingto ISO 3688:1999 or ISO 2470-1:2016.

In some embodiments, the whitened tobacco material can be characterizedas lightened in color (e.g., “whitened”) in comparison to an untreatedtobacco material. White colors are often defined with reference to theInternational Commission on Illumination's (CIE's) chromaticity diagram.The whitened tobacco material can, in certain embodiments, becharacterized as closer on the chromaticity diagram to pure white thanan untreated tobacco material.

In various embodiments, the tobacco material can be treated to extract asoluble component of the tobacco material therefrom. “Tobacco extract”as used herein refers to the isolated components of a tobacco materialthat are extracted from solid tobacco pulp by a solvent that is broughtinto contact with the tobacco material in an extraction process. Variousextraction techniques of tobacco materials can be used to provide atobacco extract and tobacco solid material. See, for example, theextraction processes described in US Pat. Appl. Pub. No. 2011/0247640 toBeeson et al., which is incorporated herein by reference. Other exampletechniques for extracting components of tobacco are described in U.S.Pat. No. 4,144,895 to Fiore; U.S. Pat. No. 4,150,677 to Osborne, Jr. etal.; U.S. Pat. No. 4,267,847 to Reid; U.S. Pat. No. 4,289,147 to Wildmanet al.; U.S. Pat. No. 4,351,346 to Brummer et al.; U.S. Pat. No.4,359,059 to Brummer et al.; U.S. Pat. No. 4,506,682 to Muller; U.S.Pat. No. 4,589,428 to Keritsis; U.S. Pat. No. 4,605,016 to Soga et al.;U.S. Pat. No. 4,716,911 to Poulose et al.; U.S. Pat. No. 4,727,889 toNiven, Jr. et al.; U.S. Pat. No. 4,887,618 to Bernasek et al.; U.S. Pat.No. 4,941,484 to Clapp et al.; U.S. Pat. No. 4,967,771 to Fagg et al.;U.S. Pat. No. 4,986,286 to Roberts et al.; U.S. Pat. No. 5,005,593 toFagg et al.; U.S. Pat. No. 5,018,540 to Grubbs et al.; U.S. Pat. No.5,060,669 to White et al.; U.S. Pat. No. 5,065,775 to Fagg; U.S. Pat.No. 5,074,319 to White et al.; U.S. Pat. No. 5,099,862 to White et al.;U.S. Pat. No. 5,121,757 to White et al.; U.S. Pat. No. 5,131,414 toFagg; U.S. Pat. No. 5,131,415 to Munoz et al.; U.S. Pat. No. 5,148,819to Fagg; U.S. Pat. No. 5,197,494 to Kramer; U.S. Pat. No. 5,230,354 toSmith et al.; U.S. Pat. No. 5,234,008 to Fagg; U.S. Pat. No. 5,243,999to Smith; U.S. Pat. No. 5,301,694 to Raymond et al.; U.S. Pat. No.5,318,050 to Gonzalez-Parra et al.; U.S. Pat. No. 5,343,879 to Teague;U.S. Pat. No. 5,360,022 to Newton; U.S. Pat. No. 5,435,325 to Clapp etal.; U.S. Pat. No. 5,445,169 to Brinkley et al.; U.S. Pat. No. 6,131,584to Lauterbach; U.S. Pat. No. 6,298,859 to Kierulff et al.; U.S. Pat. No.6,772,767 to Mua et al.; and U.S. Pat. No. 7,337,782 to Thompson, all ofwhich are incorporated by reference herein.

Typical inclusion ranges for tobacco materials can vary depending on thenature and type of the tobacco material, and the intended effect on thefinal mixture, with an example range of up to about 30% by weight (or upto about 20% by weight or up to about 10% by weight or up to about 5% byweight), based on total weight of the mixture (e.g., about 0.1 to about15% by weight).

In some embodiments, the products of the disclosure can be characterizedas completely free or substantially free of tobacco material (other thanpurified nicotine as an active ingredient). For example, certainembodiments can be characterized as having less than 1% by weight, orless than 0.5% by weight, or less than 0.1% by weight of tobaccomaterial, or 0% by weight of tobacco material.

Flavoring Agent

As used herein, a “flavoring agent” or “flavorant” is any flavorful oraromatic substance capable of altering the sensory characteristicsassociated with the oral product. Examples of sensory characteristicsthat can be modified by the flavoring agent include taste, mouthfeel,moistness, coolness/heat, and/or fragrance/aroma. Flavoring agents maybe natural or synthetic, and the character of the flavors impartedthereby may be described, without limitation, as fresh, sweet, herbal,confectionary, floral, fruity, or spicy. Specific types of flavorsinclude, but are not limited to, vanilla, coffee, chocolate/cocoa,cream, mint, spearmint, menthol, peppermint, wintergreen, eucalyptus,lavender, cardamon, nutmeg, cinnamon, clove, cascarilla, sandalwood,honey, jasmine, ginger, anise, sage, licorice, lemon, orange, apple,peach, lime, cherry, strawberry, trigeminal sensates, and anycombinations thereof. See also, Leffingwell et al., Tobacco Flavoringfor Smoking Products, R. J. Reynolds Tobacco Company (1972), which isincorporated herein by reference. Flavorings also may include componentsthat are considered moistening, cooling or smoothening agents, such aseucalyptus. These flavors may be provided neat (i.e., alone) or in acomposite, and may be employed as concentrates or flavor packages (e.g.,spearmint and menthol, orange and cinnamon; lime, pineapple, and thelike). Representative types of components also are set forth in U.S.Pat. No. 5,387,416 to White et al.; US Pat. App. Pub. No. 2005/0244521to Strickland et al.; and PCT Application Pub. No. WO 05/041699 toQuinter et al., each of which is incorporated herein by reference. Insome instances, the flavoring agent may be provided in a spray-driedform or a liquid form.

The flavoring agent generally comprises at least one volatile flavorcomponent. As used herein, “volatile” refers to a chemical substancethat forms a vapor readily at ambient temperatures (i.e., a chemicalsubstance that has a high vapor pressure at a given temperature relativeto a nonvolatile substance). Typically, a volatile flavor component hasa molecular weight below about 400 Da, and often include at least onecarbon-carbon double bond, carbon-oxygen double bond, or both. In oneembodiment, the at least one volatile flavor component comprises one ormore alcohols, aldehydes, aromatic hydrocarbons, ketones, esters,terpenes, terpenoids, or a combination thereof. Non-limiting examples ofaldehydes include vanillin, ethyl vanillin, p-anisaldehyde, hexanal,furfural, isovaleraldehyde, cuminaldehyde, benzaldehyde, andcitronellal. Non-limiting examples of ketones include1-hydroxy-2-propanone and 2-hydroxy-3-methyl-2-cyclopentenone-1-one.Non-limiting examples of esters include allyl hexanoate, ethylheptanoate, ethyl hexanoate, isoamyl acetate, and 3-methylbutyl acetate.Non-limiting examples of terpenes include sabinene, limonene,gamma-terpinene, beta-farnesene, nerolidol, thujone, myrcene, geraniol,nerol, citronellol, linalool, and eucalyptol. In one embodiment, the atleast one volatile flavor component comprises one or more of ethylvanillin, cinnamaldehyde, sabinene, limonene, gamma-terpinene,beta-farnesene, or citral. In one embodiment, the at least one volatileflavor component comprises ethyl vanillin

The amount of flavoring agent utilized in the mixture can vary, but istypically up to about 10 weight percent, and certain embodiments arecharacterized by a flavoring agent content of at least about 0.1 weightpercent, such as about 0.5 to about 10 weight percent, about 1 to about6 weight percent, or about 2 to about 5 weight percent, based on thetotal dry weight of the composition.

Salts

In some embodiments, the composition may further comprise a salt (e.g.,alkali metal salts), typically employed in an amount sufficient toprovide desired sensory attributes to the composition. Non-limitingexamples of suitable salts include sodium chloride, potassium chloride,ammonium chloride, flour salt, and the like. When present, arepresentative amount of salt is about 0.5 percent by weight or more,about 1.0 percent by weight or more, or at about 1.5 percent by weightor more, but will typically make up about 10 percent or less of thetotal dry weight of the composition, or about 7.5 percent or less orabout 5 percent or less (e.g., about 0.5 to about 5 percent by weight).

Sweeteners

The composition typically further comprises one or more sweeteners. Thesweeteners can be any sweetener or combination of sweeteners, in naturalor artificial form, or as a combination of natural and artificialsweeteners. Examples of natural sweeteners include isomaltulose,fructose, sucrose, glucose, maltose, mannose, galactose, lactose,stevia, honey, and the like. Examples of artificial sweeteners includesucralose, maltodextrin, saccharin, aspartame, acesulfame K, neotame andthe like. In some embodiments, the sweetener comprises one or more sugaralcohols. Sugar alcohols are polyols derived from monosaccharides ordisaccharides that have a partially or fully hydrogenated form. Sugaralcohols have, for example, about 4 to about 20 carbon atoms and includeerythritol, arabitol, ribitol, isomalt, maltitol, dulcitol, iditol,mannitol, xylitol, lactitol, sorbitol, and combinations thereof (e.g.,hydrogenated starch hydrolysates). When present, a representative amountof sweetener may make up from about 0.1 to about 20 percent or more ofthe of the composition by weight, for example, from about 0.1 to about1%, from about 1 to about 5%, from about 5 to about 10%, or from about10 to about 20% of the composition on a dry weight basis, based on thetotal weight of the composition.

Filler Component

The composition typically includes at least one filler, which isoptionally in particulate form. Such particulate fillers may fulfillmultiple functions, such as enhancing certain organoleptic propertiessuch as texture and mouthfeel, enhancing cohesiveness or compressibilityof the product, and the like. Generally, the fillers are particulatematerials and are cellulose-based. For example, suitable particulatefillers are any non-tobacco plant material or derivative thereof,including cellulose materials derived from such sources. Examples ofcellulosic non-tobacco plant material include cereal grains (e.g.,maize, oat, barley, rye, buckwheat, and the like), sugar beet (e.g.,FIBREX® brand filler available from International Fiber Corporation),bran fiber, and mixtures thereof. Non-limiting examples of derivativesof non-tobacco plant material include rice flour or other grain flour,starches (e.g., from potato, wheat, rice, corn), natural cellulose, andmodified cellulosic materials. Additional examples of potentialparticulate filler components include maltodextrin, dextrose, calciumcarbonate, calcium phosphate, lactose, mannitol, and sorbitol. Xylitolin liquid form can also be used as a filler material. Combinations offillers can also be used.

“Starch” as used herein may refer to pure starch from any source,modified starch, or starch derivatives. Starch is present, typically ingranular form, in almost all green plants and in various types of planttissues and organs (e.g., seeds, leaves, rhizomes, roots, tubers,shoots, fruits, grains, and stems). Starch can vary in composition, aswell as in granular shape and size. Often, starch from different sourceshas different chemical and physical characteristics. A specific starchcan be selected for inclusion in the mixture based on the ability of thestarch material to impart a specific organoleptic property tocomposition. Starches derived from various sources can be used. Forexample, major sources of starch include cereal grains (e.g., rice,wheat, and maize) and root vegetables (e.g., potatoes and cassava).Other examples of sources of starch include acorns, arrowroot,arracacha, bananas, barley, beans (e.g., favas, lentils, mung beans,peas, chickpeas), breadfruit, buckwheat, canna, chestnuts, colacasia,katakuri, kudzu, malanga, millet, oats, oca, Polynesian arrowroot, sago,sorghum, sweet potato, quinoa, rye, tapioca, taro, tobacco, waterchestnuts, and yams. Certain starches are modified starches. A modifiedstarch has undergone one or more structural modifications, oftendesigned to alter its high heat properties. Some starches have beendeveloped by genetic modifications, and are considered to be“genetically modified” starches. Other starches are obtained andsubsequently physically (e.g., heat, cool water swelling, etc.),chemically, or enzymatically modified. For example, modified starchescan be starches that have been subjected to chemical reactions, such asesterification, etherification, oxidation, depolymerization (thinning)by acid catalysis or oxidation in the presence of base, bleaching,transglycosylation and depolymerization (e.g., dextrinization in thepresence of a catalyst), cross-linking, acetylation, hydroxypropylation,and/or partial hydrolysis. Enzymatic treatment includes subjectingnative starches to enzyme isolates or concentrates, microbial enzymes,and/or enzymes native to plant materials, e.g., amylase present in cornkernels to modify corn starch. Other starches are modified by heattreatments, such as pregelatinization, dextrinization, and/or cold waterswelling processes. Certain modified starches include monostarchphosphate, distarch glycerol, distarch phosphate esterified with sodiumtrimetaphosphate, phosphate distarch phosphate, acetylated distarchphosphate, starch acetate esterified with acetic anhydride, starchacetate esterified with vinyl acetate, acetylated distarch adipate,acetylated distarch glycerol, hydroxypropyl starch, hydroxypropyldistarch glycerol, starch sodium octenyl succinate.

In some embodiments, the particulate filler component is a cellulosematerial or cellulose derivative. One particularly suitable particulatefiller component for use in the products described herein ismicrocrystalline cellulose (“MCC”). The MCC may be synthetic orsemi-synthetic, or it may be obtained entirely from natural celluloses.The MCC may be selected from the group consisting of AVICEL® gradesPH-100, PH-102, PH-103, PH-105, PH-112, PH-113, PH-200, PH-300, PH-302,VIVACEL® grades 101, 102, 12, 20 and EMOCEL® grades 50M and 90M, and thelike, and mixtures thereof. In one embodiment, the composition comprisesMCC as the particulate filler component. The quantity of MCC present inthe composition as described herein may vary according to the desiredproperties.

The amount of particulate filler component can vary, but is typically upto about 75 percent of the material by weight, based on the total dryweight of the composition. A typical range of particulate fillermaterial (e.g., MCC) within the composition can be from about 10 toabout 75 percent by total dry weight of the composition, for example,from about 10, about 15, about 20, about 25, or about 30, to about 35,about 40, about 45, or about 50 weight percent (e.g., about 20 to about50 weight percent or about 25 to about 45 weight percent). In certainembodiments, the amount of particulate filler material is at least about10 percent by weight, such as at least about 20 percent, or at leastabout 25 percent, or at least about 30 percent, or at least about 35percent, or at least about 40 percent, based on the total dry weight ofthe composition.

In one embodiment, the particulate filler component further comprises acellulose derivative or a combination of such derivatives. In someembodiments, the composition comprises from about 1 to about 10% of thecellulose derivative by weight, based on the total dry weight of thecomposition, with certain embodiments comprising about 1 to about 5% byweight of cellulose derivative. In certain embodiments, the cellulosederivative is a cellulose ether (including carboxyalkyl ethers), meaninga cellulose polymer with the hydrogen of one or more hydroxyl groups inthe cellulose structure replaced with an alkyl, hydroxyalkyl, or arylgroup. Non-limiting examples of such cellulose derivatives includemethylcellulose, hydroxypropylcellulose (“HPC”),hydroxypropylmethylcellulose (“HPMC”), hydroxyethyl cellulose, andcarboxymethylcellulose (“CMC”). In one embodiment, the cellulosederivative is one or more of methylcellulose, HPC, HPMC, hydroxyethylcellulose, and CMC. In one embodiment, the cellulose derivative is HPC.In some embodiments, the composition comprises from about 1 to about 3%HPC by weight, based on the total dry weight of the composition.

Water

The water content of the composition described herein, prior to use by aconsumer of the product, may vary according to the desired properties.Typically, the mixture, as present within the product prior to insertioninto the mouth of the user, is less than about 60 percent by weight ofwater, and generally is from about 1 to about 60% by weight of water,for example, from about 5 to about 55, about 10 to about 50, about 20 toabout 45, or about 25 to about 40 percent water by weight, includingwater amounts of at least about 5% by weight, at least about 10% byweight, at least about 15% by weight, and at least about 20% by weight.

Humectants

In certain embodiments, one or more humectants may be employed in thecomposition. Examples of humectants include, but are not limited to,glycerin, propylene glycol, and the like. It is noted that certainhumectants can also function as plasticizers useful in embodiments ofthe oral compositions described herein, as described in more detailabove. Where included, the humectant is typically provided in an amountsufficient to provide desired moisture attributes to the composition.Further, in some instances, the humectant may impart desirable flowcharacteristics to the composition for depositing in a mold. Whenpresent, a humectant will typically make up about 5% or less of the dryweight of the composition (e.g., from about 0.5 to about 5% by weight).When present, a representative amount of humectant is about 0.1% toabout 1% by weight, or about 1% to about 5% by weight, based on thetotal dry weight of the composition.

Buffering Agents

In certain embodiments, the composition of the present disclosure cancomprise pH adjusters or buffering agents. Examples of pH adjusters andbuffering agents that can be used include, but are not limited to, metalhydroxides (e.g., alkali metal hydroxides such as sodium hydroxide andpotassium hydroxide), and other alkali metal buffers such as metalcarbonates (e.g., potassium carbonate or sodium carbonate), or metalbicarbonates such as sodium bicarbonate, and the like. Where present,the buffering agent is typically present in an amount less than about 5percent based on the dry weight of the composition, for example, fromabout 0.1% to about 5%, such as, e.g., from about 0.75% to about 4%,from about 0.75% to about 3%, or from about 1% to about 2% by weight,based on the total dry weight. Non-limiting examples of suitable buffersinclude alkali metals acetates, glycinates, phosphates,glycerophosphates, citrates, carbonates, hydrogen carbonates, borates,or mixtures thereof.

Colorants

A colorant may be employed in amounts sufficient to provide the desiredphysical attributes to the composition. Examples of colorants includevarious dyes and pigments, such as caramel coloring and titaniumdioxide. The amount of colorant utilized in the composition can vary,but when present is typically up to about 3 weight percent, such as fromabout 0.1%, about 0.5%, or about 1%, to about 3% by weight, based on thetotal dry weight.

Other Additives

Other additives can be included in the disclosed composition. Forexample, the composition can be processed, blended, formulated, combinedand/or mixed with other materials or ingredients. The additives can beartificial, or can be obtained or derived from herbal or biologicalsources. Examples of further types of additives include thickening orgelling agents (e.g., fish gelatin), emulsifiers, oral care additives(e.g., thyme oil, eucalyptus oil, and zinc), preservatives (e.g.,potassium sorbate and the like), zinc or magnesium salts selected to berelatively water soluble for compositions with greater water solubility(e.g., magnesium or zinc gluconate) or selected to be relatively waterinsoluble for compositions with reduced water solubility (e.g.,magnesium or zinc oxide), disintegration aids, or combinations thereof.See, for example, those representative components, combination ofcomponents, relative amounts of those components, and manners andmethods for employing those components, set forth in U.S. Pat. No.9,237,769 to Mua et al., U.S. Pat. No. 7,861,728 to Holton, Jr. et al.,US Pat. App. Pub. No. 2010/0291245 to Gao et al., and US Pat. App. Pub.No. 2007/0062549 to Holton, Jr. et al., each of which is incorporatedherein by reference. Typical inclusion ranges for such additionaladditives can vary depending on the nature and function of the additiveand the intended effect on the final composition, with an example rangeof up to about 10% by weight, based on total dry weight (e.g., about 0.1to about 5% by weight).

The aforementioned additives can be employed together (e.g., as additiveformulations) or separately (e.g., individual additive components can beadded at different stages involved in the preparation of the finalmixture). Furthermore, the aforementioned types of additives may beencapsulated as provided in the final product or mixture. Exampleencapsulated additives are described, for example, in WO2010/132444 toAtchley, which has been previously incorporated by reference herein.

In some embodiments, any one or more of a filler component, a tobaccomaterial, and the overall oral product described herein can be describedas a particulate material. As used herein, the term “particulate” refersto a material in the form of a plurality of individual particles, someof which can be in the form of an agglomerate of multiple particles,wherein the particles have an average length to width ratio less than2:1, such as less than 1.5:1, such as about 1:1. In various embodiments,the particles of a particulate material can be described assubstantially spherical or granular.

The particle size of a particulate material may be measured by sieveanalysis. As the skilled person will readily appreciate, sieve analysis(otherwise known as a gradation test) is a method used to measure theparticle size distribution of a particulate material. Typically, sieveanalysis involves a nested column of sieves which comprise screens,preferably in the form of wire mesh cloths. A pre-weighed sample may beintroduced into the top or uppermost sieve in the column, which has thelargest screen openings or mesh size (i.e. the largest pore diameter ofthe sieve). Each lower sieve in the column has progressively smallerscreen openings or mesh sizes than the sieve above. Typically, at thebase of the column of sieves is a receiver portion to collect anyparticles having a particle size smaller than the screen opening size ormesh size of the bottom or lowermost sieve in the column (which has thesmallest screen opening or mesh size).

In some embodiments, the column of sieves may be placed on or in amechanical agitator. The agitator causes the vibration of each of thesieves in the column The mechanical agitator may be activated for apre-determined period of time in order to ensure that all particles arecollected in the correct sieve. In some embodiments, the column ofsieves is agitated for a period of time from 0.5 minutes to 10 minutes,such as from 1 minute to 10 minutes, such as from 1 minute to 5 minutes,such as for approximately 3 minutes. Once the agitation of the sieves inthe column is complete, the material collected on each sieve is weighed.The weight of each sample on each sieve may then be divided by the totalweight in order to obtain a percentage of the mass retained on eachsieve. As the skilled person will readily appreciate, the screen openingsizes or mesh sizes for each sieve in the column used for sieve analysismay be selected based on the granularity or known maximum/minimumparticle sizes of the sample to be analysed. In some embodiments, acolumn of sieves may be used for sieve analysis, wherein the columncomprises from 2 to 20 sieves, such as from 5 to 15 sieves. In someembodiments, a column of sieves may be used for sieve analysis, whereinthe column comprises 10 sieves. In some embodiments, the largest screenopening or mesh sizes of the sieves used for sieve analysis may be 1000μm, such as 500 μm, such as 400 μm, such as 300 μm.

In some embodiments, any particulate material referenced herein (e.g.,filler component, tobacco material, and the overall oral product) can becharacterized as having at least 50% by weight of particles with aparticle size as measured by sieve analysis of no greater than about1000 μm, such as no greater than about 500 μm, such as no greater thanabout 400 μm, such as no greater than about 350 μm, such as no greaterthan about 300 μm. In some embodiments, at least 60% by weight of theparticles of any particulate material referenced herein have a particlesize as measured by sieve analysis of no greater than about 1000 μm,such as no greater than about 500 μm, such as no greater than about 400μm, such as no greater than about 350 μm, such as no greater than about300 μm. In some embodiments, at least 70% by weight of the particles ofany particulate material referenced herein have a particle size asmeasured by sieve analysis of no greater than about 1000 μm, such as nogreater than about 500 μm, such as no greater than about 400 μm, such asno greater than about 350 μm, such as no greater than about 300 μm. Insome embodiments, at least 80% by weight of the particles of anyparticulate material referenced herein have a particle size as measuredby sieve analysis of no greater than about 1000 μm, such as no greaterthan about 500 μm, such as no greater than about 400 μm, such as nogreater than about 350 μm, such as no greater than about 300 μm. In someembodiments, at least 90% by weight of the particles of any particulatematerial referenced herein have a particle size as measured by sieveanalysis of no greater than about 1000 μm, such as no greater than about500 μm, such as no greater than about 400 μm, such as no greater thanabout 350 μm, such as no greater than about 300 μm. In some embodiments,at least 95% by weight of the particles of any particulate materialreferenced herein have a particle size as measured by sieve analysis ofno greater than about 1000 μm, such as no greater than about 500 μm,such as no greater than about 400 μm, such as no greater than about 350μm, such as no greater than about 300 μm. In some embodiments, at least99% by weight of the particles of any particulate material referencedherein have a particle size as measured by sieve analysis of no greaterthan about 1000 μm, such as no greater than about 500 μm, such as nogreater than about 400 μm, such as no greater than about 350 μm, such asno greater than about 300 μm. In some embodiments, approximately 100% byweight of the particles of any particulate material referenced hereinhave a particle size as measured by sieve analysis of no greater thanabout 1000 μm, such as no greater than about 500 μm, such as no greaterthan about 400 μm, such as no greater than about 350 μm, such as nogreater than about 300 μm.

In some embodiments, at least 50% by weight, such as at least 60% byweight, such as at least 70% by weight, such as at least 80% by weight,such as at least 90% by weight, such as at least 95% by weight, such asat least 99% by weight of the particles of any particulate materialreferenced herein have a particle size as measured by sieve analysis offrom about 0.01 μm to about 1000 μm, such as from about 0.05 μm to about750 μm, such as from about 0.1 μm to about 500 μm, such as from about0.25 μm to about 500 μm. In some embodiments, at least 50% by weight,such as at least 60% by weight, such as at least 70% by weight, such asat least 80% by weight, such as at least 90% by weight, such as at least95% by weight, such as at least 99% by weight of the particles of anyparticulate material referenced herein have a particle size as measuredby sieve analysis of from about 10 μm to about 400 μm, such as fromabout 50 μm to about 350 gm, such as from about 100 μm to about 350 μm,such as from about 200 μm to about 300 μm. In certain embodiments, atleast a portion of the particles have a particle size as measured bysieve analysis of about 100 μm or less, about 50 μm or less, or about 30μm or less.

Preparation of the Oral Product

The manner by which the various components of the composition can becombined may vary. The various components of the formulation may becontacted, combined, or mixed together in conical-type blenders, mixingdrums, ribbon blenders, or the like. As such, the overall mixture ofvarious components (i.e., the active ingredient(s) and/or flavorant(s),the thermoplastic binder system, and any other ingredients) may berelatively uniform in nature. See also, for example, the types ofmethodologies set forth in U.S. Pat. No. 4,148,325 to Solomon et al.;U.S. Pat. No. 6,510,855 to Korte et al.; and U.S. Pat. No. 6,834,654 toWilliams, each of which is incorporated herein by reference. Thecomponents of the oral product formulation can be brought together inadmixture using any mixing technique or equipment known in the art.Various components noted herein, which may be in liquid or dry solidform, can be admixed in a pretreatment step prior to mixture with anyremaining components of the composition, or the mixture components canbe simply mixed all together. Any mixing method that brings the oralcomposition ingredients into intimate contact can be used. A mixingapparatus featuring an impeller or other structure capable of agitationis typically used. Example mixing equipment includes casing drums,conditioning cylinders or drums, liquid spray apparatus, ribbonblenders, mixers available as FKM130, FKM600, FKM1200, FKM2000 andFKM3000 from Littleford Day, Inc., Plough Share types of mixercylinders, and the like.

The manner that the oral product is formed can vary, and various methodsfor forming processed oral products or for producing processed oralproducts will be readily apparent to those skilled in the art of oralproduct manufacture. For example, suitably heated oral formulationsincorporating thermoplastic binder systems and having a pourable,formable or generally liquid character can be cast into a sheet-likeform and cooled to yield a sheet-like oral product. As another example,suitably heated oral product formulations incorporating thermoplasticbinder systems can be molded into a desired shape and cooled. Exampleshapes of formed oral products include pill, tablet, sphere, sheet,film, coin, cube, bead, ovoid, obloid, bean, cylinder, stick, and rod.As yet another example, oral product formulations incorporatingthermoplastic binder systems can be extruded from heated extrusiondevices and cooled. As another example, oral product formulationsincorporating a binder system and a pre-mixed plasticizer blend can beextruded from heated extrusion devices and cooled.

The oral product can be manufactured using hot melt extrusiontechniques. As such, processed oral product formulations can besubjected to sufficient heat during formation of oral product toeliminate the need for any additional heat treatment steps. For example,flashing off the moisture from a processed oral product formulationduring a hot melt extrusion process can eliminate any need for furtherheating, drying, or the like.

Processed oral product formulations, such as multi-layered pellets, canbe manufactured using a wide variety of extrusion techniques. Forexample, multi-layered pellets can be manufactured using co-extrusiontechniques (e.g., using twin screw extruders). In such a situation,successive wet or dry components or component mixtures can be placedwithin separate extrusion hoppers. Steam, gases (e.g., ammonia, air,carbon dioxide, and the like), plasticizers (e.g., glycerin or propyleneglycol), and a plasticizer blend can be injected into the extruderbarrel as each dry mix is propelled, plasticized, and cooked. As such,the various components are processed so as to be very well mixed, andhence, come in complete contact with each other. For example, thecontact of components is such that individual components can be wellembedded in the extrusion matrix or extrudate. See, for example, U.S.Pat. No. 4,821,749 to Toft et al., which is incorporated herein byreference. Multilayered materials can have the general form of films,and alternatively, multi-layered generally spherical materials canpossess various layers extending from the inside outward.

Some shapes of oral products, such as rods or cubes, can be formed byfirst extruding the material through a die having the desiredcross-section (e.g., round or square) and then optionally cutting theextruded material into desired lengths. For example, extruder equipmentcomprising single or multiple screw extruders can by employed to formthe shape of a product according to the present disclosure. Someextruders can comprise twin screw extruders which comprise co-rotatingtwin screw extruders. Various screw configurations can be employed. Forexample, screws having combinations of elements for feeding, mixing,pumping, shearing, and the like, can be selected as desired for optimumresults. Screws having sections or elements which provide relativelylarge output capacities, which have interrupted or nonconjugatedflights, or which are “counterflighted” or “reversing” also can beemployed. Typical screw elements as well as screws having combinationsof such elements are available from extruder manufacturers. An extrudercan provide a barrel for heating of the materials which are introducedwithin the extruder. The extruder barrel can comprise multiple barrelzones. The conditions of the extrusion set-up can vary, for example, inmodifying feed rate of dry blend ingredients, feed rate of wet blendingredients, screw RPM setting, temperature conditions, aperture diedimensions, barrel zone entry point for certain ingredients, as well asadditional parameters.

Techniques and equipment for extruding oral product materials have beenset forth in U.S. Pat. No. 3,098,492 to Wursburg; U.S. Pat. No.4,874,000 to Tamol et al.; U.S. Pat. No. 4,880,018 to Graves et al.;U.S. Pat. No. 4,989,620 to Keritsis et al.; U.S. Pat. No. 5,072,744 toLuke et al.; U.S. Pat. No. 5,829,453 to White et al.; and U.S. Pat. No.6,182,670 to White et al.; each of which is incorporated herein byreference. Example extrusion equipment suitable for use includeindustrial pasta extruders such as Model TP 200/300 available fromEmiliomiti, LLC of Italy, and the ZSK model twin screw extruder fromCoperion Corp, Ramsey, N.J.

In some methods that can be used to produce oral products, a portion ofthe ingredients can be mixed and fed into the extruder. Additionalingredients can be introduced to the extruder at a different point orbarrel zone as compared to other ingredients. For example, a pre-mixedsubgroup of ingredients can be fed into a first barrel zone of theextruder to contact a dry mix of other ingredients. A hopper orplurality of hoppers can be employed to facilitate the input of variousingredients into an extruder.

Processed sheet-like materials can be prepared by applying the oralproduct composition onto a moving belt and passing the moving beltthrough a nip formed by opposing rollers, followed by cutting the sheetinto desired lengths. Alternatively, the oral product can be over-coatedwith powdered or liquid coating. Furthermore, if desired, the surface ofthe oral product can be embossed or printed.

EXAMPLES

The present invention can be more fully illustrated by the followingexamples, which are set forth to illustrate some embodiments of thepresent invention and are not to be construed as limiting thereof. Allweight percentages are expressed on a dry weight basis, meaning watercontent is excluded, unless otherwise indicated.

Example 1 Binder System Formulations

Tables A-M provide various embodiments of a binder system that can beincorporated into a composition for use in an oral productrepresentative of the present disclosure. The binder system preparedaccording to the recipes shown in Tables A-M can be used within the oralproduct formulations found in the examples described hereinafter.

Each batch of binder system is prepared by mixing the components in acommercially available Kitchen Aid mixer for about 3 to 5 minutes.

TABLE A Batch 1 Ingredients wt % g hydroxypropyl methylcellulose 70 350Propylene Glycol 30 150 Total ingredients: 100% 500

TABLE B Batch 2 Ingredients wt % g hydroxypropyl methylcellulose 42 210Propylene Glycol 28 140 Water 30 150 Total ingredients: 100% 500

TABLE C Batch 3 Ingredients wt % g Xanthan 42 210 Maltodextrin 28 140Propylene Glycol 30 150 Total ingredients: 100% 500

TABLE D Batch 4 Ingredients wt % g Xanthan 29.4 147 Maltodextrin 19.6 98Propylene Glycol 21 105 Water 30 150 Total ingredients: 100% 500

TABLE E Batch 5 Ingredients wt % g Gum Arabic 42 210 Propylene Glycol 28140 Water 30 150 Total ingredients: 100% 500

TABLE F Batch 6 Ingredients wt % g Xanthan gum 21.7 108.5 Gum Arabic33.6 168 polyvinylpyrrolidone 14.7 73.5 Propylene Glycol 30 150 Totalingredients: 100% 500

TABLE G Batch 7 Ingredients wt % g Gum Arabic 60 300 Maltodextrin 15 75Propylene Glycol 25 125 Total ingredients: 100% 500

TABLE H Batch 8 Ingredients wt % g Maltodextrin 73 365 Propylene Glycol27 135 Total ingredients: 100% 500

TABLE I Batch 9 Ingredients wt % g Modified Starch 75 375 PropyleneGlycol 25 125 Total ingredients: 100% 500

TABLE J Batch 10 Ingredients wt % g Modified Starch 65 325 Maltodextrin10 50 Propylene Glycol 25 125 Total ingredients: 100% 500

TABLE K Batch 11 Ingredients wt % g Pullulan 42 210 Maltodextrin 28 140Propylene Glycol 30 150 Total ingredients: 100% 500

TABLE L Batch 12 Ingredients wt % g Pullulan 29.4 147 Maltodextrin 19.698 Propylene Glycol 21 105 Water 30 150 Total ingredients: 100% 500

TABLE M Batch 13 Ingredients wt % g Pullulan 21.7 108.5 Gum Arabic 33.6168 polyvinylpyrrolidone 14.7 73.5 Propylene Glycol 30 150 Totalingredients: 100% 500

Example 2

Oral product formulations for use as a stick type of an oral product asset forth in Table 1 are provided in the following manner

Except for glycerin, all dry ingredients, in powder form, are addedtogether with a batch formulation and thoroughly mixed. Each batchformulation is prepared by mixing propylene glycol and/or water with abinder in a Kitchen Aid mixer for about 5 minutes, before being mixedwith other dry ingredients. The nicotine can be added to the bindersystem before adding to the dry ingredients. Each mixed formulation isthen commuted into the hopper of an extruder. The extruder is operatedat a temperature of about 65° C. to 100° C., and the screw speed is setat 60 rpm. The formulation is fed through the extruder and 3 5 mm longsticks are prepared.

TABLE 1 Ingredients Weight % Nicotine     1-5% Salt  0.5-7.5 Buffer0.1-5 Sweetener 0.1-5 Colorant 0.1-3 Filler   5-75 Flavorant  0.1-10Other Additive(s)  0.1-20 Binder System (One of Table A-M)  20-50 Totalingredients: 100

Example 3

Example 2 is generally repeated, but a sheet type product is formedhaving the general formula of Table 1. All ingredients are addedtogether and thoroughly mixed before being commuted into an extruder.The extruder is set at a screw speed of 45-60 rpm and the barrelsections and die operated at temperatures of about 75-100° C. A sheetingdie is employed. The formulation is extruded into a continuous sheetthat is about 0.85 mm thick. The sheet is extruded onto a conveyor beltand transferred through a cooling tunnel.

The sheet is further reduced in thickness by passage through pin rolls,and is flattened into a sheet having a thickness of less than 0.4 mm.The sheet is finally cut into bite-size strip pieces of various shapes(e.g., pieces of about 2 cm by 2 cm).

Many modifications and other embodiments of the invention will come tomind to one skilled in the art to which this invention pertains havingthe benefit of the teachings presented in the foregoing description.Therefore, it is to be understood that the invention is not to belimited to the specific embodiments disclosed and that modifications andother embodiments are intended to be included within the scope of theappended claims. Although specific terms are employed herein, they areused in a generic and descriptive sense only and not for purposes oflimitation.

1. A composition, comprising: a thermoplastic binder system in an amountof at least about 5% percent by weight, based on total dry weight of thecomposition; and at least one of a flavoring agent and an activeingredient; wherein the thermoplastic binder system comprises at leastone thermoplastic polymer and at least one plasticizer; wherein thecomposition is substantially free of unbleached tobacco material,excluding any nicotine component present.
 2. The composition of claim 1,wherein the at least one thermoplastic polymer is selected from thegroup consisting of cellulose ethers, polyvinyl alcohol, polyvinylacetate, aliphatic polyester, polyvinyl polypyrrolidone, maltodextrin,pullulan, polyethylene oxide, natural gums, and blends thereof.
 3. Thecomposition of claim 1, wherein the at least one thermoplastic polymeris a cellulose ether selected from the group consisting of hydroxypropylcellulose, ethylcellulose, hydroxypropyl methylcellulose, and blendsthereof.
 4. The composition of claim 1, wherein the at least onethermoplastic polymer exhibits thermoplastic behavior at temperaturesless than about 100° C.
 5. The composition of claim 1, wherein thethermoplastic binder system comprises at least one of pullulan, gumarabic, and xanthan gum.
 6. The composition of claim 1, wherein the atleast one plasticizer comprises a plasticizer selected from the groupconsisting of glycerin, propylene glycol, polypropylene glycol,polyethylene glycol, sorbitol, maltitol, polyglycitol, erythritol,isomalt, xylitol, mannitol, and blends thereof.
 7. The composition ofclaim 1, wherein the at least one plasticizer is in the form of aplasticizer blend comprising: at least one of sorbitol, maltitol, andpolyglycitol; at least one of erythritol, isomalt, xylitol, andmannitol; and at least one of glycerin, propylene glycol, polypropyleneglycol, and polyethylene glycol.
 8. The composition of claim 1, whereinthe at least one thermoplastic polymer has a softening temperature, andwherein the at least one plasticizer is capable of lowering thesoftening temperature by about 20° C. or more.
 9. The composition ofclaim 1, wherein the active ingredient is selected from the groupconsisting of a nicotine component, botanicals, nutraceuticals,stimulants, amino acids, vitamins, cannabinoids cannabimimetics,terpenes, and combinations thereof.
 10. The composition of claim 1,comprising from about 0.001 to about 10% by weight of a nicotinecomponent, calculated as the free base and based on the total dry weightof the composition.
 11. The composition of claim 1, wherein thecomposition is substantially free of tobacco material, excluding anynicotine component present.
 12. The composition of claim 1, wherein thethermoplastic binder system is present in an amount of at least about20% percent by weight, based on total dry weight of the composition. 13.The composition of claim 1, comprising: about 5 to about 50% by dryweight thermoplastic binding system; about 5 to about 75% by dry weightof filler; about 0.1 to about 5% by dry weight of sweetener; about 0.5to about 7.5% by dry weight of salt; and about 1 to about 10% by dryweight of one or more active ingredients, flavoring agents, orcombinations thereof.
 14. A method of forming a composition, comprising:contacting a thermoplastic binder system with at least one of an activeingredient and a flavorant to provide a mixture; subjecting the mixtureto an elevated temperature; forming the mixture into a desired shape ofan oral product; and cooling the oral product; wherein the thermoplasticbinder system comprises at least one thermoplastic polymer and at leastone plasticizer; wherein the composition is substantially free ofunbleached tobacco material, excluding any nicotine component present.15. The method of claim 14, wherein the at least one thermoplasticpolymer is selected from the group consisting of cellulose ethers,polyvinyl alcohol, polyvinyl acetate, aliphatic polyester, polyvinylpolypyrrolidone, maltodextrin, pullulan, polyethylene oxide, naturalgums, and blends thereof.
 16. The method of claim 14, wherein the atleast one thermoplastic polymer exhibits thermoplastic behavior attemperatures less than about 100° C.
 17. The method of claim 14, whereinthe at least one plasticizer comprises a plasticizer selected from thegroup consisting of glycerin, propylene glycol, polypropylene glycol,polyethylene glycol, sorbitol, maltitol, polyglycitol, erythritol,isomalt, xylitol, mannitol, and blends thereof.
 18. The method of claim14, wherein the active ingredient is selected from the group consistingof a nicotine component, botanicals, nutraceuticals, stimulants, aminoacids, vitamins, cannabinoids, cannabimimetics, terpenes, andcombinations thereof.
 19. The method of claim 14, wherein thecomposition is substantially free of tobacco material, excluding anynicotine component present.
 20. The method of claim 14, wherein thethermoplastic binder system is present in an amount of at least about10% percent by weight, based on total dry weight of the composition.